**Sexual and Contraceptive Behavior studies on Plan B**

**A Literature Review**

#### SUMMARY

The sponsor submitted five published and three unpublished studies of
varying quality that assess the effects of advance provision of
emergency contraception on sexual and contraceptive behaviors. When
reviewing these studies as a body of evidence, the quality or
applicability of each study must be considered. While most of the
studies state that they were randomized, only one study (Ellertson) used
a random number generator as the method of randomization. The other
studies used systems such as date of clinic visit or other less
desirable systems. The two unpublished studies would not have received
peer review (although Gold et. al was recently accepted for publication
by the Journal Of Pediatric and Adolescent Gynecology). Three of the
studies were performed in foreign countries and may have limited
generalizability to the United States. The overall summary of eight
behavioral studies is presented below and in Table 1 followed by the
individual reviews.

**STUDY DESIGN**

1.  ***Study Location***: Five studies were conducted in the USA and one
    each was conducted in the UK, Africa and India.

2.  ***Subjects:*** All subjects in the eight studies were recruited
    from family planning clinics (the purposes for visiting the clinics
    were EC consultation, post-abortion follow-up and postpartum
    evaluation). The age range was 15-45 years with most enrollees being
    around 20 years old.

3.  ***Study Groups:*** Subjects were randomly (in most studies)
    assigned to the following 2 or 3 groups. All subjects received
    education regarding emergency contraception use (this is in
    contradistinction to the actual use study submitted by the sponsor
    where education was not given to the subjects enrolled in the study,
    thereby more closely mimicking an OTC environment).

> [Advance EC Group]{.underline}: Subjects received in advance one
> course of EC pills in six studies and three courses of EC pills in two
> studies (one in US and one on India);
>
> [Control Group]{.underline}: Subjects received EC education only
> (including advice on where to get and how to use EC) except for one
> study where EC education was not given in the control group;
>
> [Pharmacy EC Access Group]{.underline}: Subjects received EC when
> needed from pharmacy in one US study (in California).

4.  ***Sample Size:*** Number of subjects ranged from 160 to 1020 in the
    five US studies and 210-1083 in three studies outside US.

5.  ***Follow-up Period:*** Subjects were followed from 8 weeks up to 1
    year after admission to the studies.

**RESULTS**

1.  ***EC Use:*** All studies suggest that the advance EC provision
    increase EC use. This supported the hypothesis of the studies that
    easier access would translate into increased use.

2.  ***Unprotected Sex:*** In these studies, unprotected sex was defined
    as lack of use of a contraceptive. All studies demonstrated that
    compared to baseline, the advance EC group and control group had
    decreased frequency of unprotected sex. In some studies, the
    decrease in unprotected sex was greater in the control group.

3.  ***Condom Use:*** One US study (sponsored by Women's Capital
    Corporation) suggests that the advance, pharmacy and standard EC
    access groups plus EC education had an increase in more effective
    methods of contraception with a corresponding decrease in condom
    use. The other 6 studies either demonstrated no significant decrease
    in condom use with advance EC provision or in education alone
    (control groups) or demonstrated that "used condoms every time"
    increased in treatment and control groups when compared to baseline.

4.  ***Consistent Use of Regular Contraception:*** Most of the studies
    demonstrate that women in both the treatment and control groups
    increase their use of a regular contraception compared to baseline.
    One US study suggest that women with advance EC access are more
    likely to use less-effective contraception (although they had less
    unprotected sex compared to baseline and increased "condom use every
    time" from 12% at baseline to 47% at study completion), and another
    US study showed higher frequency of missing oral contraceptive pills
    in subjects provided with advance EC than those in control.

**COMMENTS**

1.  These studies were not conducted in a simulated OTC setting.
    However, several of the studies would have recruited a similar
    subject population as that used in the actual use study. The main
    difference in design would be that subjects in the literature review
    would have received education compared to the subjects in the actual
    use study and would have received an advanced provision of EC.

2.  Subjects were recruited exclusively from clinic sites and received
    EC education during enrollment (except one study in which control
    subjects did not receive EC education), which can not be
    generalizable to the OTC population.

3.  Study population in each study was a subset of general population
    and was heterogeneous among all these studies. This diversity is
    desirable reflecting many subgroups and capturing the many aspects
    of an OTC population. The similarity of results is also reassuring
    in that the different subsets tend to exhibit the same behavioral
    trends.

4.  Most studies provided only one course of advance EC. In those
    studies, after the one course of EC pills were used, subjects in the
    advance EC group would have the same accessibility to EC as the
    control group.

5.  Subjects recruited and studies conducted outside US may not be
    extrapolated to US population.

6.  There were limitations of design and/or methodology of the studies
    and conclusions should be considered in that context.

**CONCLUSION**

1.  The literature review studies suggests that the advance access of
    emergency contraception did not increase the likelihood of
    unprotected sex in women populations who visited family planning
    clinics. The study duration's ranged from 4-12 months in follow-up.
    The results may provide certain supportive evidence to resolve some
    issues raised from the actual use study (such as whether consistent
    use of routine contraception persist greater than the one month of
    observation in the actual use study data submitted by the sponsors).

2.  The studies did not simulate an OTC setting although some of the
    studies have recruited similar subject populations as those enrolled
    in the actual use study.

3.  Most of the studies demonstrate that women in both the treatment and
    control groups increase their use of a routine contraception (less
    unprotected sex) compared to baseline.

4.  Most of the studies either demonstrated no significant decrease in
    condom use with advance EC provision and control groups or
    demonstrated that "used condoms every time" increased in treatment
    and control groups when compared to baseline

***Table 1.* Effects of Emergency Contraception under Advance Provision
on Sexual and Contraceptive Behavior**

+------+----------+------+--------+------+----------+--------------+
| **Au | **Study  | **S  | **Subj | *    | **       |              |
| thor | Design** | tudy | ects** | *Fol | *Advance |              |
| &    |          | Lo   |        | low- | EC       |              |
| P    |          | cati |        | up** | Access   |              |
| ubli |          | on** |        |      | caused   |              |
| cati |          |      |        | **P  | changes  |              |
| on** |          |      |        | erio | in***    |              |
|      |          |      |        | ds** |          |              |
+======+==========+======+========+======+==========+==============+
|      |          |      |        |      | **Sexual | **C          |
|      |          |      |        |      | Be       | ontraceptive |
|      |          |      |        |      | havior** | Behavior**   |
+------+----------+------+--------+------+----------+--------------+
| R    | Non-ra   | **   | 263    | 4    | Decrease | More likely  |
| aine | ndomized | *USA | women  | mo   | in       | to use less  |
| et   | 2        | ,*** |        | nths | unp      | effective    |
| al:  | groups:  | Fa   | age    |      | rotected | c            |
|      |          | mily | 16-24  |      | sex in   | ontraception |
| *Ob  | Advance  | plan | (64%   |      | both     | (increased   |
| stet | EC (one  | ning | a      |      | groups   | condom use)  |
| Gyne | EC       | cli  | dolesc |      | vs.      |              |
| col* | course)  | nics | ents); |      | baseline | Increased EC |
|      | &        |      | 32%    |      | (Cont    | use;         |
| 2000 | Control  |      | Latina |      | rol\>Tx) |              |
|      | (EC      |      | & 29%  |      |          |              |
| Li   | ed       |      | AA;    |      |          |              |
| tera | ucation) |      |        |      |          |              |
| ture |          |      | Ex     |      |          |              |
| #1   |          |      | cluded |      |          |              |
|      |          |      | su     |      |          |              |
|      |          |      | bjects |      |          |              |
|      |          |      | pres   |      |          |              |
|      |          |      | enting |      |          |              |
|      |          |      | for EC |      |          |              |
+------+----------+------+--------+------+----------+--------------+
| R    | Ra       | **   | 1020   | 6    | Decrease | Increase in  |
| aine | ndomized | *USA | women  | mo   | in       | OC use in    |
| et   | 3        | ,*** |        | nths | unp      | all 3 groups |
| al:  | groups:  | Fa   | age    |      | rotected | with an      |
|      |          | mily | 15-24  |      | sex in   | offset       |
| UCSF | Advance  | plan | years  |      | all 3    | decrease in  |
| S    | EC       | ning | (20±3  |      | groups   | condom use   |
| tudy | P        | cli  | yrs);  |      | *vs.*    | in all 3     |
|      | rovision | nics |        |      | baseline | groups       |
| *(   |          |      | 20%    |      | (SA      | Decrease in  |
| NDA: | (3 EC    |      | Latina |      | \>PA\>AP | condom use   |
| vol  | c        |      | &      |      | (p\<0.05 | greatest in  |
| 13,  | ourses), |      |        |      | in PA &  | AP & PA      |
| p1   |          |      | 17% AA |      | SA       | groups       |
| 34)* | Pharmacy |      |        |      | groups)  |              |
|      | EC       |      | Ex     |      |          |              |
| Unp  | Access;  |      | cluded |      | No       |              |
| ubli |          |      | su     |      | increase |              |
| shed | Standard |      | bjects |      | in       |              |
|      | EC       |      | pres   |      | i        |              |
| Li   | Access   |      | enting |      | ncidence |              |
| tera |          |      | for EC |      | of STDs  |              |
| ture |          |      |        |      | compared |              |
| #2   |          |      |        |      | to Stnd  |              |
|      |          |      |        |      | EC       |              |
|      |          |      |        |      | Access   |              |
+------+----------+------+--------+------+----------+--------------+
| Jac  | Ra       | **   | 370    | 6    | I        | No change in |
| kson | ndomized | *USA | Post   | mo   | ncreased | routine      |
| et   | 2 groups | ,*** | partum | nths | co       | c            |
| al,  | by date  | In   | women  | &    | nsistent | ontraception |
|      | of       | ner- |        |      | use      | and condom   |
| *Ob  | hospital | city | age    | 12   | contr    | use;         |
| stet | admin:   | hosp | 26±6   | mo   | aception |              |
| Gyne |          | ital | yrs    | nths | and more | Increase in  |
| col* | Advance  |      |        |      | e        | EC use.      |
| 2003 | EC (one  |      | 72%    |      | ffective |              |
|      | EC       |      | L      |      | method   |              |
| Li   | course)  |      | atina; |      | in both  |              |
| tera | &        |      |        |      | groups.  |              |
| ture | Control  |      | 43%    |      | No       |              |
| #3   | (***but  |      | M      |      | increase |              |
|      | no EC    |      | arried |      | in       |              |
|      | educa    |      |        |      | report   |              |
|      | tion***) |      |        |      | of       |              |
|      |          |      |        |      | unp      |              |
|      |          |      |        |      | rotected |              |
|      |          |      |        |      | sex      |              |
+------+----------+------+--------+------+----------+--------------+
| Be   | Ra       | **   | 160    | 6    | No       | No decrease  |
| lzer | ndomized | *USA | adol   | mo   | increase | in condom    |
| et   | 2        | ,*** | escent | nths | in       | use and      |
| al:  | groups:  | In   | m      |      | unp      | primary      |
|      |          | ner- | others |      | rotected | c            |
| *J   | Advance  | city |        |      | sex (but | ontraception |
| Adol | EC (one  |      | age    |      | limited  | between      |
| Hea  | EC       | (unk | 14-20  |      | data     | groups. No   |
| lth* | course)  | nown | yrs;   |      | av       | data         |
| (Ab  | &        | s    |        |      | ailable) | provided on  |
| stra | Control  | ite) | 83%    |      |          | within group |
| ct), |          |      | Latina |      |          | changes;     |
| 2003 |          |      | &      |      |          |              |
|      |          |      |        |      |          | (limited     |
| Li   |          |      | 16% AA |      |          | data         |
| tera |          |      |        |      |          | available)   |
| ture |          |      |        |      |          |              |
| #4   |          |      |        |      |          | Increase in  |
|      |          |      |        |      |          | EC use       |
+------+----------+------+--------+------+----------+--------------+
| G    | Ra       | **   | 301    | 8    | No       | No decrease  |
| old: | ndomized | *USA | adol   | mo   | increase | in condom    |
|      | 2        | ,*** | escent | nths | in       | use;         |
| *Unp | groups:  | an   | women  |      | unp      |              |
| ubli |          | u    |        |      | rotected | Other info   |
| shed | Advance  | rban | age    |      | int      | not          |
| Man  | EC (one  | ho   | 15-20  |      | ercourse | available    |
| uscr | EC       | spit | (      |      |          |              |
| ipt* | course)  | al-b | 17±2); |      | No       |              |
|      | &        | ased |        |      | increase |              |
| Li   | Control  | ad   | 58% AA |      | in STDs  |              |
| tera |          | oles |        |      | compared |              |
| ture |          | cent |        |      | to       |              |
| #5   |          | cl   |        |      | control  |              |
|      |          | inic |        |      |          |              |
+------+----------+------+--------+------+----------+--------------+
| Gla  | Ra       | *    | 1083   | 1-   | Decrease | Increase in  |
| sier | ndomized | **UK | women  | year | in       | OC use in    |
| &    | 2 groups | ,*** |        |      | unp      | both groups  |
| Ba   | by birth | Fa   | age    |      | rotected | with         |
| ird: | date:    | mily | 16-44  |      | sex in   | decrease in  |
| *New |          | plan | (23%   |      | both     | condom use   |
| Eng  | Advance  | ning | age    |      | groups   | similar      |
| J    | EC (one  | cli  | 1      |      | vs.      | changes      |
| Med* | EC       | nics | 6-20), |      | b        | between 2    |
| 1998 | course)  |      | 2      |      | aseline. | groups.      |
|      | &        |      | 0%\>30 |      |          |              |
| Li   | Control  |      | y/o    |      |          | Increase EC  |
| tera | (EC      |      |        |      |          | use.         |
| ture | ed       |      | Post   |      |          |              |
| #6   | ucation) |      | EC or  |      |          |              |
|      |          |      | Thera  |      |          |              |
|      |          |      | peutic |      |          |              |
|      |          |      | ab     |      |          |              |
|      |          |      | ortion |      |          |              |
+------+----------+------+--------+------+----------+--------------+
| Lov  | Non-ra   | *    | 211    | 8    | Decrease | Increase EC  |
| vorn | ndomized | **Af | women  | w    | in       | use;         |
| et   | 2        | rica | (sper  | eeks | unp      |              |
| al:  | groups:  | ,*** | micide |      | rotected | Other info   |
|      |          | Fa   | users) |      | sex      | not          |
| *Co  | Advance  | mily |        |      | compared | reported.    |
| ntra | EC (one  | plan | age    |      | to       |              |
| cept | EC       | ning | 18-45  |      | baseline | Significant  |
| ion* | course)  | cli  | yrs    |      | in both  | flaws in     |
|      | &        | nics |        |      | groups   | study        |
| 2000 | Control  |      |        |      | (Contr   | design.      |
|      | (EC      |      |        |      | ol\>AEC) |              |
| Li   | ed       |      |        |      |          |              |
| tera | ucation) |      |        |      | Sig      |              |
| ture |          |      |        |      | nificant |              |
| #7   |          |      |        |      | lim      |              |
|      |          |      |        |      | itations |              |
|      |          |      |        |      | in study |              |
|      |          |      |        |      | design.  |              |
+------+----------+------+--------+------+----------+--------------+
| E    | Ra       | ***I | 411    | 12   | Similar  | Increase EC  |
| ller | ndomized | ndia | women  | mo   | pr       | use.         |
| tson | 2 group: | ,*** |        | nths | oportion |              |
| et   |          | fa   | (      | (38% | having   |              |
| al:  | Advance  | mily | condom | 1    | unp      |              |
|      | EC (3 EC | plan | u      | 2-mo | rotected |              |
| *Ob  | course)  | ning | sers); | nth; | sex vs.  |              |
| etet | &        | cli  |        | 90%  | the      |              |
| Gyne | Control  | nics | age    | 3    | control  |              |
| col* |          |      | 25±4   | -mon |          |              |
|      |          |      | yrs    | th); |          |              |
| 2001 |          |      | (83%   | pts  |          |              |
|      |          |      | 20-29  | off  |          |              |
| Li   |          |      | yr);   | s    |          |              |
| tera |          |      |        | tudy |          |              |
| ture |          |      | B      | if   |          |              |
| #8   |          |      | arrier | swit |          |              |
|      |          |      | method | ched |          |              |
|      |          |      | users  | to   |          |              |
|      |          |      |        | more |          |              |
|      |          |      |        | reli |          |              |
|      |          |      |        | able |          |              |
|      |          |      |        | me   |          |              |
|      |          |      |        | thod |          |              |
|      |          |      |        | (    |          |              |
|      |          |      |        | 23%) |          |              |
+------+----------+------+--------+------+----------+--------------+

Information in the table is extracted and summarized from the individual
literature reviews as attached in the following pages.

***The Advance EC (AEC) or the Advance EC Provision (AP) or
Treatment(Tx) group :*** Subjects received EC pills in advance plus EC
education at the enrollment.

***The Control or Standard EC access (SA) group:*** Subjects received
only EC education (except the Jackson's study, Literature #3) and were
advised to request EC pills from the clinics (the same sites as the
advance group) by prescription when needed.

***The Pharmacy EC Access (PA) group:*** Subjects received EC pills from
pharmacy without prescription.

OC: Oral Birth Control Pills; AA: Africa American; EC: Emergency
Contraception; STDs: sexually transmitted diseases;

***Table 1 (Cont).* Effects of Emergency Contraception under Advance
Provision on Sexual and Contraceptive Behavior**

***Literature* #1** (vol. 13, page 068)

**Emergency Contraception: Advance Provision in a Young, High-Risk
Clinic Population**

**Author:** Tina Raine, Cynthia Harper, Kathleen Leon, and Philip Darney

**Affiliate:** Department of Obstetrics, Gynecology, and Reproductive
Sciences

> Center for Reproductive Health Research and Policy
>
> University of California, San Francisco, California.

**Sponsor:** Compton Foundation, Menlo Park, California

> Fred Gellert Family Foundation, San Francisco, California.

**Study Location: *USA,*** Family Planning Clinics, San Francisco,
California

> From June to November 1998

**Publication:** ***Obstet Gynecol*** 96:1--7, 2000

**Design:** Single-center, ***non-randomized***, clinical trial;

4-month follow-up

Single course of Advance EC Provision

**METHODS**

**Subject**

A total of 263 female subjects were recruited and enrolled from a family
planning clinic of San Francisco General Hospital between June and
November 1998.

> ***Inclusion criteria:***
>
> Women age 16--24 years
>
> Able to speak English or Spanish
>
> Available for follow-up in 4 months.
>
> ***Exclusion criteria:***
>
> Pregnancy
>
> Using contraceptive implants
>
> Using intrauterine devices
>
> Presentation for emergency contraception
>
> Contraindications to oral contraceptive (OC) pills.

The subjects were assigned on an ***alternating basis*** into the
following 2 groups:

***Treatment groups:*** 130 subjects received EC education and one
course of EC pills (comprised 8 OC pills; each contained 0.15 mg of
levonorgestrel and 30 ug of ethinyl estradiol).

***Control group:*** 133 subjects received EC education alone.

**Data Collection**

Research assistants interviewed subjects at enrollment and at follow-up
(at 4 month by telephone or clinic visit) using a questionnaire to
obtain demographic information and to measure outcomes, including
contraceptive methods and patterns of use.

**Data Analysis**

All analyses were conducted using the intent-to-treat population, with
all study subjects analyzed according to their initial group assignment.
Differences between Treatment and Control were analyzed with a
Chi-square test for categorical variables and t tests for continuous
variables. A multiple logistic regression analysis was used to determine
the effect of advance provision of emergency contraception on use at
follow-up.

**RESULTS**

**Subject Demographics**

Only age and race/ethnicity were reported in the article, as summarized
in Table 1. The mean age was 19 years (64% adolescents). Most subjects
were minorities. The demographic distribution between 2 groups was
similar.

***Table 1.* Demographics of Subjects**

(% of enrolled subjects)

+------------------------+--------------+--------------+--------------+
| **Demographic**        | *            | **Control**  | **Total**    |
|                        | *Treatment** |              |              |
|                        |              | **n=133**    | **n=263**    |
|                        | **n=130**    |              |              |
+------------------------+--------------+--------------+--------------+
| > Mean age (years)     | > 19.2       | > 18.8       | > 19.0       |
+------------------------+--------------+--------------+--------------+
| > Race or ethnicity    |              |              |              |
+------------------------+--------------+--------------+--------------+
| > Hispanic             | > 33.1       | > 30.1       | > 31.6       |
+------------------------+--------------+--------------+--------------+
| > Black                | > 26.2       | > 31.6       | > 28.9       |
+------------------------+--------------+--------------+--------------+
| > White                | > 16.9       | > 12.8       | > 14.8       |
+------------------------+--------------+--------------+--------------+
| > Asian                | > 14.6       | > 16.5       | > 15.6       |
+------------------------+--------------+--------------+--------------+
| > Other (biracial)     | > 9.2        | > 9.0        | > 9.1        |
+------------------------+--------------+--------------+--------------+
| > Primary language     | > 16.2       | > 14.3       | > 15.2       |
| > Spanish              |              |              |              |
+------------------------+--------------+--------------+--------------+

> Data were extracted from the author's Table 1.

**Baseline Characteristics**

At enrollment the sexual activity, contraception, pregnancy history and
reasons for clinic visit were comparable between treatment and control
groups (Table 2), except that the history of unprotected sex was lower
in the treatment group than in control group (15% vs. 24%). The most
common contraception method used by the study population was condoms,
and a higher proportion of subjects in the treatment arm reported at
baseline that they used condoms for contraception than in the control
arm (47% vs. 39%). At baseline a higher proportion of the subjects in
the control arm reported that their use of either condoms or oral
contraceptives was consistent (used condoms every time, never missed
pills) than subjects in the treatment arm. Consistent condom use was
reported in 24% of control subjects who used condoms compared to 12% on
the treatment arm. Consistent use of oral contraceptives was reported in
42% of the control subjects who used oral contraceptives, compared to
25% on the treatment arm.

The table below demonstrates that the subjects in the treatment arm
reported higher frequency of sexual acts, higher proportion of condom
use as a method of contraception, lower rate of unprotected sex, higher
proportion with a history of elective abortion, higher proportion with a
history of pregnancy and more births. More subjects in the treatment arm
presented to the clinic visit for an "infection check".

***Table 2.* Baseline Traits of Subjects at enrollment**

(% of enrolled subjects)

+------------------------------+-----------+------------+------------+
| **Baseline Characteristics** | **Tr      | *          | **Total**  |
|                              | eatment** | *Control** |            |
|                              |           |            | **n=263**  |
|                              | **n=130** | **n=133**  |            |
+------------------------------+-----------+------------+------------+
| > ***Reason for clinic       |           |            |            |
| > visit\****                 |           |            |            |
+------------------------------+-----------+------------+------------+
| > Papanicoloau smear or      | 16.2      | 19.5       | 17.9       |
| > check-up                   |           |            |            |
+------------------------------+-----------+------------+------------+
| > Contraception              | 39.2      | 32.3       | 35.8       |
+------------------------------+-----------+------------+------------+
| > Follow-up abortion         | 7.7       | 6.8        | 7.2        |
+------------------------------+-----------+------------+------------+
| > Pregnancy test             | 37.7      | 44.4       | 41.4       |
+------------------------------+-----------+------------+------------+
| > Infection check            | 20.8      | 13.6       | 17.1       |
+------------------------------+-----------+------------+------------+
| > ***First visit to          | 38.8      | 40.6       | 39.7       |
| > clinic***                  |           |            |            |
+------------------------------+-----------+------------+------------+
| > ***Pregnancy History***    |           |            |            |
+------------------------------+-----------+------------+------------+
| > Ever pregnant              | 56.2      | 47.4       | 51.7       |
+------------------------------+-----------+------------+------------+
| > Ever gave birth            | 20.8      | 16.5       | 18.6       |
+------------------------------+-----------+------------+------------+
| > Ever had an elective       | 40.8      | 34.6       | 37.6       |
| > abortion                   |           |            |            |
+------------------------------+-----------+------------+------------+
| > ***History of sexually     | 18.6      | 18.0       | 18.3       |
| > transmitted disease***     |           |            |            |
+------------------------------+-----------+------------+------------+
| > ***Sexual Acts in past 4   |           |            |            |
| > months***                  |           |            |            |
+------------------------------+-----------+------------+------------+
| > None                       | 3.8       | 5.3        | 4.6        |
+------------------------------+-----------+------------+------------+
| > Sporadic^†^                | 33.9      | 39.8       | 36.9       |
+------------------------------+-----------+------------+------------+
| > Once a week                | 25.4      | 27.8       | 26.6       |
+------------------------------+-----------+------------+------------+
| > More than once a week      | 36.9      | 27.1       | 31.9       |
+------------------------------+-----------+------------+------------+
| > New sexual partner         | 23.1      | 21.0       | 22.0       |
+------------------------------+-----------+------------+------------+
| > ***Current                 |           |            |            |
| > contraception^‡^***        |           |            |            |
+------------------------------+-----------+------------+------------+
| > Condoms                    | **46.9**  | **39.1**   | 43.0       |
+------------------------------+-----------+------------+------------+
| > Oral contraceptive         | 27.7      | 24.8       | 26.2       |
+------------------------------+-----------+------------+------------+
| > Depot medroxyprogesterone  | 10.0      | 11.3       | 10.6       |
| > acetate                    |           |            |            |
+------------------------------+-----------+------------+------------+
| > Other                      | 0.7       | 0.8        | 0.8        |
+------------------------------+-----------+------------+------------+
| > None (unprotected sex?)    | **14.6**  | **24.1**   | 19.4       |
+------------------------------+-----------+------------+------------+
| > Dual use (hormonal with    | 16.9      | 17.3       | 17.1       |
| > condoms)                   |           |            |            |
+------------------------------+-----------+------------+------------+

\* Participant might have had more than one reason for clinic visit.

† Sporadic: once or twice in past 4 months or once to twice a month.

‡ Current contraception: most effective method reported if more than one
used.

**Changes in Sexual and Contraceptive Behavior (Table 5)**

***EC Use:***

-   Women in the treatment group were significantly more likely to use
    emergency contraceptives than those in control groups (20% *vs.* 7%,
    p=0.006). This difference between treatment arms remained
    statistically significant in multiple logistic regression analyses
    that evaluated the impact of contraceptive method, pattern of
    contraceptive use at enrollment and frequency of unprotected sex
    reported at enrollment.

-   Overall EC use increased from enrollment to follow-up (4% *vs.* 14%)
    in both groups, with more increase in the treatment group.

***Routine Contraception:***

-   Women in the treatment group were more likely to have switched to a
    less-effective contraception method than those in the control groups
    at the time of follow-up (28% *vs.* 17%, p=0.05). (Level of
    effectiveness was ordered from most effective to least effective for
    this analysis as follows: depot, oral contraceptive, barrier, none.)
    The proportion that didn't change method or continued to use no
    method at all was similar between arms at the time of follow-up.

-   Women in the treatment group tended to be less likely to use more
    effective contraception than those in the control groups (20% *vs.*
    29%, p=0.1).

-   The proportion of women in the treatment group who reported
    consistent oral contraceptive (OC) use was less than in the control
    group at baseline (25% vs. 42%, p=0.08) Although the proportion
    reporting consistent oral contraceptive use remained lower on the
    treatment arm relative to the control arm at the time of follow-up
    (32% *vs.* 58%, p=0.03), the proportion of subjects who reported
    consistent use increased in both groups at the time of follow-up.

***Unprotected Sex***:

-   Overall "never had unprotected sex" (had protected sex) increased at
    the follow-up as compared to that at the enrollment (33% *vs.* 56%).
    As compared to the baseline, increase in protected sex was 18% (from
    32% to 50%) in the treatment group and 28% (from 34% to 62%) in the
    control group (no statistical tests were available).

***Condom Use:***

-   Condom use increased in both groups at follow-up as compared to at
    enrollment (Treatment group: 12% *vs.* 47.4%, Control group: 24.3%
    vs 50%).

-   There were no significant difference at the time of follow-up
    between treatment and control groups in the proportion of condom
    use.

-   Since there was less condom use at baseline in the treatment group
    than in control group, the proportionate increase in condom use in
    the treatment group was greater than in control group (4x increase
    *vs.* 2x increase).

***Table 5.* Contraceptive Behavior during the Study Period Compared to
Baseline**

**Between Treatment and Control Groups**

(% of enrolled subjects)

+----------------------------+----------+----------+----------+-------+
| **Contraceptive Behavior** | **Tre    | **C      | *        | **    |
|                            | atment** | ontrol** | *Total** | *P*** |
|                            |          |          |          |       |
|                            | **%      | **%      | **%      |       |
|                            | (*n*)**  | (*n*)**  | (*n*)**  |       |
+----------------------------+----------+----------+----------+-------+
| > ***Initial (at           |          |          |          |       |
| > Enrollment)***           |          |          |          |       |
+----------------------------+----------+----------+----------+-------+
| > Never had unprotected    | > 32.3   | > 33.8   | > 33.1   | >     |
| > sex                      | > (42)   | > (45)   | > (87)   |  0.92 |
+----------------------------+----------+----------+----------+-------+
| > Used condoms every time  | > **12.0 | > **24.3 | > 17.8   | >     |
|                            | > (10)** | > (18)** | > (28)   |  0.08 |
+----------------------------+----------+----------+----------+-------+
| > OC users who never       | > **25.0 | > **42.2 | > 33.7   | >     |
| > missed pills             | > (11)** | > (19)** | > (30)   |  0.08 |
+----------------------------+----------+----------+----------+-------+
| > Used emergency           | > 4.6    | > 3.0    | > 3.8    | >     |
| > contraception            | > (6)    | > (4)    | > (10)   |  0.75 |
+----------------------------+----------+----------+----------+-------+
| > ***Follow-up***          |          |          |          |       |
+----------------------------+----------+----------+----------+-------+
| > Never had unprotected    | > 50.4   | > 61.8   | > 55.9   | >     |
| > sex                      | > (56)   | > (63)   | > (119)  |  0.42 |
+----------------------------+----------+----------+----------+-------+
| > Used condoms every time  | > 47.4   | > 50.0   | > 48.7   | >     |
|                            | > (18)   | > (19)   | > (37)   |  0.71 |
+----------------------------+----------+----------+----------+-------+
| > OC users who never       | > **31.7 | > **57.8 | > 45.4   | >     |
| > missed pills             | > (13)** | > (26)** | > (39)   |  0.03 |
+----------------------------+----------+----------+----------+-------+
| > Used emergency           | > **19.8 | > **6.9  | > 13.6   | >     |
| > contraception            | > (22)** | > (7)**  | > (29)   | 0.006 |
+----------------------------+----------+----------+----------+-------+
| > More effective method†   | > **19.8 | > **29.4 | > 24.4   | >     |
|                            | > (22)** | > (30)** | > (52)   |  0.10 |
+----------------------------+----------+----------+----------+-------+
| > Less effective method‡   | > **27.9 | > **16.7 | > 22.5   | >     |
|                            | > (31)** | > (17)** | > (48)   |  0.05 |
+----------------------------+----------+----------+----------+-------+
| > ***No method***          | > 7.2    | > 6.9    | > 7.0    | >     |
| >                          | > (8)    | > (7)    | > (15)   |  0.92 |
| > at enrollment and        |          |          |          |       |
| > follow-up                |          |          |          |       |
+----------------------------+----------+----------+----------+-------+
| > ***Same method***        | > 45.0   | > 47.1   | > 46.0   | >     |
| >                          | > (50)   | > (48)   | > (98)   |  0.77 |
| > at enrollment and        |          |          |          |       |
| > follow-up                |          |          |          |       |
+----------------------------+----------+----------+----------+-------+

Data are extracted from the author's Tables 2, 4 and 5.

† More effective methods: Depot medroxyprogesterone acetate and OC; and
‡ less effective methods: spermicides, diaphragms, and withdrawal.

**COMMENTS**

1.  The subjects were not randomly assigned. This created an imbalance
    at baseline (unprotected sex, condom use, missed OC pills and EC
    use) and could have introduced bias into the study. This is a major
    flaw and limits conclusions.

2.  Only a single course of EC was provided to the treatment group
    (advance provision), so the study observation may not truly reflect
    changes in sexual and contraceptive behaviors that may occur in the
    OTC setting.

3.  Information on education, literacy level, and income of subjects
    were not provided. Given the non-randomized design there are no
    assurances of an even distribution of these demographics.

4.  Sample size was small (n=130 in the Advance group and n=133 in the
    Control group).

5.  Subjects were recruited from clinical sites and were high risk,
    which may not be generalizable to OTC population.

**CONCLUSION**

This study demonstrated the following: Compared to their baseline, women
age 16-24 with advance EC provision are::

-   Less likely to have unprotected sex

-   More likely to use condoms (every time)

-   More likely to use EC pills

-   More consistent with their use of OC pills

-   Compared to the control group, the women provided with Advance EC
    were more likely to switch to a less effective routine contraception
    method and have a higher proportional increase in condom use

When compared to the treatment group, the control group was more likely
to have a greater absolute change in "Never had unprotected sex" and
"Never missed pills". However, it should also be noted that at baseline,
the treatment group appeared to potentially be a higher risk group
compared to the control group, with a greater percentage of subjects
that were presenting to the clinic for contraception, infection checks,
had been pregnant, had given birth, had an elective abortion, had a new
sexual partner in the past 4 months and had an elective abortion.
Because of these imbalances at baseline, between group comparisons
should be made with caution.

***Literature #2:* UCSF Study** #H9738-18501-02

(Vol. 32/p134; EDR dated 2003-09-08)

**Provision of Emergency Contraception to Women enrolled in the study
prior to December 31, 2001: Pharmacy Access and Advance Distribution
Evaluation**

**Investigator:** UCSF (by Tina Raine, et al)

**Sponsor:** Women's Capital Corporation

**Study Location: *USA,*** Family Planning clinics four clinical (San
Francisco)

> July 9, 2001 to December 31, 2001

**Report Date:** January 30, 2003 (prepared by Pinney Associates)

**Published:** Not

**Study Design:** Randomized 3-arm clinical trial

> 6-12-month follow-up

3 courses of advance EC.

**Primary objectives:**

> To compare the rates of unintended pregnancy and sexually transmitted
> disease (STD) among three different distributions (***advance
> provision, pharmacy access and standard access***) for emergency
> contraception.

**Secondary objectives:**

> To assess the effects of the three different emergency contraception
> distribution methods on ***sexual and contraceptive behaviors***, such
> as the frequency of unprotected sex, and use of condoms, oral
> contraceptives, and emergency contraception use.

**METHODS**

**Subjects**

Subjects were recruited from four family planning clinic sites (Table 1)
in the San Francisco bay area (CA) with the following inclusion and
exclusion criteria.

***Inclusion Criteria***

-   Women age 15-24 at high risk for unintended pregnancies

-   Speak either Spanish or English

-   Be available in 6 months for a follow-up visit.

***Exclusion Criteria***

-   Women were currently pregnant;

-   Actively trying to get pregnant;

-   Sterilized; using Depo-Provera, IUD, Norplant or Lunelle;

-   Reported having had unprotected sexual intercourse in the past 3
    days.

-   Women who presented to the clinic specifically requesting emergency
    contraception (*the rationale was not specified*)

***Table 1.* Enrolled subjects and follow-up compliance from 4 clinical
sites**

+---------------------------+----------+----------+---------+---------+
| **Clinical Sites**        | **Ph     | **A      | **Sta   | **      |
|                           | armacy** | dvance** | ndard** | Total** |
| **(San Francisco, CA)**   |          |          |         |         |
|                           | **       | **Pro    | **A     | **(N =  |
|                           | Access** | vision** | ccess** | 1020)** |
|                           |          |          |         |         |
|                           | **(N =   | **(N =   | **(N =  |         |
|                           | 343)**   | 340)**   | 337)**  |         |
+---------------------------+----------+----------+---------+---------+
| > City College            | > 30     | > 29     | > 31    | > 90    |
|                           | > (96.8) | > (90.6) | >       | >       |
|                           |          |          |  (96.9) |  (94.7) |
+---------------------------+----------+----------+---------+---------+
| > Planned Parenthood:     | > 44     | > 42     | > 40    | > 126   |
| > Dale City               | > (97.8) | > (95.5) | >       | >       |
|                           |          |          |  (88.9) |  (94.0) |
+---------------------------+----------+----------+---------+---------+
| > New Generations         | > 136    | > 141    | > 128   | > 405   |
|                           | > (91.9) | > (95.9) | >       | >       |
|                           |          |          |  (90.8) |  (92.9) |
+---------------------------+----------+----------+---------+---------+
| > Planned Parenthood: San | > 104    | > 104    | > 107   | > 315   |
| > Francisco               | > (87.4) | > (88.9) | >       | >       |
|                           |          |          |  (89.9) |  (88.7) |
+---------------------------+----------+----------+---------+---------+

Data were adapted from the author's Table 4 (p6).

***Subject Disposition***

Of 2012 screened women, 1,020 were enrolled (see below) and randomly
assigned into 3 groups.

> Total approached women: 2,012 (100%)
>
> Total screened women: 1,804 (89.7%)
>
> Ineligible women: 992 (49.3%)
>
> Eligible women: 1,024 (56.7%)
>
> Enrolled subjects: 1,020 (56.4%)
>
> **Pharmacy Access (PA)**: Subjects in this group obtained Plan B at
> the local pharmacy without a prescription through a collaborative
> agreement between clinics and pharmacies;
>
> **Advance Provision (AP)**: Subjects were given Plan B (3 complete
> packages) to take home and use as needed;
>
> **Standard Access (SA)**: Subjects returned to the clinic to obtain
> supplies.

All subjects received information and counseling on emergency
contraception, and were reimbursed \$10 (during the visit). They were
also reimbursed \$20 for completing the follow-up visit procedure.

**Data Collection**

***Baseline data:*** urine tests (for pregnancy, Chlamydia and
gonorrhea) and blood test (for HSV-2 antibody) and interview (for
demographics, sexual history, knowledge of emergency contraception).

***Follow-up visit:*** occurred 6 months or more (up to 1 year) after
enrollment. Data were collected on sexual history, use of emergency
contraception, urine test (for pregnancy, Chlamydia, and gonorrhea), and
blood test (for HSV-2 antibody).

**Data Analysis**

One-way analysis of variance, contingency table analyses, and a
Chi-square test were used for different variables. In cases of small
numbers, when cells had fewer than 5 observations, the Fisher's exact
test was conducted. All analyses were evaluated at the two-tailed
probability level of p\<0.05 and no adjustments were made for the number
of analyses or pair-wise comparison.

**RESULTS**

**Subject Demographics**

Demographic characteristics of the enrolled subjects are summarized in
Table 2. Overall they were comparable among the 3 study groups. Races
(white, black, Latina, and Asian) were evenly distributed among 3
groups. The following were the major characteristics:

> Mean age: 20±2.6 (15-24) years
>
> Marital status: 86% single
>
> Active sex (within 6 months): 100%
>
> Unprotected intercourse (within 6 months): 50%
>
> Currently using condoms: 67%
>
> Currently using oral contraceptives: 41%
>
> Previous emergency contraception: 35%
>
> Education and literacy level: unknown (not reported).

A third of participants reported having been pregnant previously, with
9% reporting ever given birth.

**Follow-up Compliance**

Approximately 92% of subjects (936 of 1,020) in each group completed
follow-up assessment within one year (211±39 days) (Table 3).

***Table 2.* Demographics of subjects**

+------------------+-----------+------------+------------+------------+
| **Demographics** | **P       | *          | **         | **Total**  |
|                  | harmacy** | *Advance** | Standard** |            |
|                  |           |            |            | **(N =     |
|                  | *         | **P        | **Access** | 936)**     |
|                  | *Access** | rovision** |            |            |
|                  |           |            | **(N =     |            |
|                  | **(N =    | **(N =     | 306)**     |            |
|                  | 314)**    | 316)**     |            |            |
+------------------+-----------+------------+------------+------------+
| > ***Age         |           |            |            |            |
| > (years)***     |           |            |            |            |
+------------------+-----------+------------+------------+------------+
| > Mean ± SD      | > 19.7 ±  | > 19.7 ±   | > 19.9 ±   | > 19.7 ±   |
|                  | > 2.6     | > 2.6      | > 2.6      | > 2.6      |
+------------------+-----------+------------+------------+------------+
| > ***Race***     |           |            |            |            |
+------------------+-----------+------------+------------+------------+
| > Latina         | > 66      | > 64       | > 60       | > 190      |
|                  | > (21.0)  | > (20.3)   | > (19.6)   | > (20.3)   |
+------------------+-----------+------------+------------+------------+
| > Black          | > 53      | > 54       | > 52       | > 159      |
|                  | > (16.9)  | > (17.1)   | > (17.0)   | > (17.0)   |
+------------------+-----------+------------+------------+------------+
| > White          | > 79      | > 100      | > 83       | > 262      |
|                  | > (25.2)  | > (31.7)   | > (27.1)   | > (28.0)   |
+------------------+-----------+------------+------------+------------+
| > Asian/Pacific  | > 57      | > 62       | > 69       | > 188      |
| > Islander       | > (18.2)  | > (19.6)   | > (22.6)   | > (20.1)   |
+------------------+-----------+------------+------------+------------+
| > Multiracial    | > 48      | > 29 (9.2) | > 35       | > 122      |
|                  | > (15.3)  |            | > (11.4)   | > (12.0)   |
+------------------+-----------+------------+------------+------------+
| > Other          | > 11      | > 7 (2.2)  | > 7 (2.3)  | > 25 (2.7) |
|                  | > (3.5)   |            |            |            |
+------------------+-----------+------------+------------+------------+
| > ***Marital     |           |            |            |            |
| > Status***      |           |            |            |            |
+------------------+-----------+------------+------------+------------+
| > Single         | > 263     | > 273      | > 271      | > 807      |
|                  | > (83.8)  | > (86.4)   | > (88.6)   | > (86.2)   |
+------------------+-----------+------------+------------+------------+
| > Cohabiting     | > 42      | > 31 (9.8) | > 28 (9.2) | > 101      |
|                  | > (13.4)  |            |            | > (10.8)   |
+------------------+-----------+------------+------------+------------+
| > Married        | > 7 (2.2) | > 10 (3.2) | > 6 (2.0)  | > 23 (2.5) |
+------------------+-----------+------------+------------+------------+
| > Married, but   | > 2 (0.6) | > \-       | > \-       | > 2 (0.2)  |
| > separated      |           |            |            |            |
+------------------+-----------+------------+------------+------------+
| > Divorced       | > \-      | > 2 (0.6)  | > 1 (0.3)  | > 3 (0.3)  |
+------------------+-----------+------------+------------+------------+
| > Widowed        | > \-      | > \-       | > \-       | > \-       |
+------------------+-----------+------------+------------+------------+

Data were extracted from the author's Table 5 (p7) and presented as "No.
(%)."

***Table 3.* Subject Disposition at Follow-up**

+---------------+-------------+--------------+------------+-----------+
| > **          | >           | > **Advance  | >          | >         |
| Disposition** |  **Pharmacy | >            | **Standard | **Total** |
|               | > Access**  |  Provision** | > Access** | >         |
|               | >           | >            | >          | > ***No.  |
|               | > ***No.    | > ***No.     | > ***No.   | > (%)***  |
|               | > (%)***    | > (%)***     | > (%)***   |           |
+---------------+-------------+--------------+------------+-----------+
| > **Enrolled  | > 343       | > 340        | > 337      | > 1020    |
| > Subjects**  |             |              |            |           |
+---------------+-------------+--------------+------------+-----------+
| > **Lost to   | > 23 (6.7)  | > 23 (6.8)   | > 27 (8.0) | > 73      |
| > Follow-up** |             |              |            | > (7.2)   |
+---------------+-------------+--------------+------------+-----------+
| > **Refused   | > 6 (1.8)   | > 1 (0.3)    | > 4 (1.2)  | > 11      |
| > Follow-up** |             |              |            | > (1.1)   |
+---------------+-------------+--------------+------------+-----------+
| >             | > **314     | > **316      | > **306    | > **936   |
| **Completed** | > (91.6)**  | > (92.9)**   | > (90.8)** | >         |
| >             |             |              |            |  (91.8)** |
| > **          |             |              |            |           |
| Follow-up\*** |             |              |            |           |
+---------------+-------------+--------------+------------+-----------+

\* Mean follow-up days (post-baseline) was 211±39 days, median follow-up
days: 195 days. There were no statistical differences in demographics of
subjects between Lost-to-Follow-up and Completed-Follow-up.

**Sexual and Contraceptive Behavior**

***Pregnancy:***

The overall pregnancy rate (Table 4) in the 936 subjects who completed
the follow-up interview was 8%. There were no differences in pregnancy
rate among 3 groups including when analysis was controlled for baseline
history of pregnancy (p\<0.89, Chi-square test).

***Sexually Transmitted Diseases (STDs):***

Subjects were considered to have acquired an STD during the follow-up
period if they were positive for herpes (new diagnosis), chlamydia,
gonorrhea (self-reported *or* by laboratory tests), trichomonas, PID
(self-reported). There were no differences in STD acquisition among 3
groups when controlling for baseline history of STDs (p\<0.427,
Chi-square test).

***Table 4.* Pregnancy and STD during study**

+----------+----------+----------+-----------+-----------+-----------+
| **O      |          | **Ph     | **        | **S       | **Total** |
| utcome** |          | armacy** | Advance** | tandard** |           |
|          |          |          |           |           | **(N =    |
|          |          | **       | **Pr      | *         | 936)**    |
|          |          | Access** | ovision** | *Access** |           |
|          |          |          |           |           |           |
|          |          | **(N =   | **(N =    | **(N =    |           |
|          |          | 314)**   | 316)**    | 306)**    |           |
+----------+----------+----------+-----------+-----------+-----------+
| > **Pre  | >        | > 108    | > 97      | > 99      | > 304     |
| gnancy** | Previous | > (34.4) | > (30.7)  | > (32.5)  | > (32.5)  |
+----------+----------+----------+-----------+-----------+-----------+
|          | > F      | > 24     | > 26      | > 25      | > 75      |
|          | ollow-up | > (7.6)  | > (8.2)   | > (8.2)   | > (8.0)   |
+----------+----------+----------+-----------+-----------+-----------+
| > **     | >        | > 62     | > 69      | > 77      | > 208     |
| STDs\*** |  History | > (19.8) | > (21.8)  | > (25.4)  | > (22.3)  |
+----------+----------+----------+-----------+-----------+-----------+
|          | >        | > 58     | > 47      | > 51      | > 156     |
|          | Acquired | > (18.5) | > (14.9)  | > (16.7)  | > (16.7)  |
|          | > during |          |           |           |           |
|          | > Study  |          |           |           |           |
+----------+----------+----------+-----------+-----------+-----------+

Data were extracted from author's Tables 6, 7 & 8 (p8-9) and presented
as "No. (%)."

\* STDs at follow-up were newly acquired (not included baseline).

***Emergency Contraception (Table 5):***

Overall 29% (269 of 936) of subjects used emergency contraception during
the study period.

1.  Subjects were more likely to use emergency contraception in the
    Advance Provision group (39.2%) than in the Pharmacy Access group
    (26.5%) or in the Standard Access group (20.3%); they were also more
    likely to report convenience of emergency contraception compared to
    those in the Pharmacy Access group or the Standard Access group
    (96%, 87% and 87%, respectively).

2.  There were no differences in the time to take the first pill among
    the 3 groups or in overall proper use of emergency contraception
    (p\>0.05). Subjects in the Standard Access group tended to have
    higher correct use than other 2 groups, 97% (SA), 92% (AP) and 90%
    (PA), and were more likely (100%) to take the second pill than the
    Advance Provision group (93%) and the Pharmacy Access group (90%).
    It should be noted that the time interval for use of the second pill
    was not defined in this study as it was in the actual use study (12
    hours after first pill).

3.  The proportion of repeat use was highest in the Advance Provision
    group. The baseline EC use was 35% for the entire study population.

***Table 5.* Emergency Contraception Usage during Study**

+----------------+-------------+------------+------------+------------+
| **EC Use**     | *           | *          | **         | **All      |
|                | *Pharmacy** | *Advance** | Standard** | Subjects** |
|                |             |            |            |            |
|                | **Access**  | **P        | **Access** | **(N =     |
|                |             | rovision** |            | 936)**     |
|                | **(N =      |            | **(N =     |            |
|                | 314)**      | **(N =     | 306)**     |            |
|                |             | 316)**     |            |            |
+----------------+-------------+------------+------------+------------+
| > Total\*      | > 83 (26.5) | > 124      | > 62       | > 269      |
|                |             | > (39.2)   | > (20.3)   | > (28.8)   |
+----------------+-------------+------------+------------+------------+
| > Never        | > 230       | > 192      | > 244      | > 666      |
|                | > (73.5)    | > (60.8)   | > (79.7)   | > (71.2)   |
+----------------+-------------+------------+------------+------------+
| > One time     | > 52 (16.6) | > 75       | > 45       | > 172      |
|                |             | > (23.7)   | > (14.7)   | > (18.4)   |
+----------------+-------------+------------+------------+------------+
| > Two times    | > 20 (6.4)  | > 28 (8.9) | > 13 (4.3) | > 61 (6.5) |
+----------------+-------------+------------+------------+------------+
| > \> 3 times   | > 11 (3.5)  | > 21 (6.7) | > 4 (1.3)  | > 36 (3.8) |
+----------------+-------------+------------+------------+------------+

> Data were extracted from the author's Table 10 (p13) and presented as
> "No. (%).
>
> \*Pair-wise comparisons: AP vs. PA (p\<0.001), AP vs. SA (p\<0.001),
> and PA vs. SA (p\<0.067).

***Sexual behavior (Table 6):***

Overall 96.6% (903 of 936) were sexually active during the study period.

1.  There were no statistically significant differences in the rates of
    unprotected sex among the 3 groups. Subjects in the Advance
    Provision group tended to have higher frequency of unprotected
    intercourse (47% in AP, 41% in PA and SA).

2.  As compared to the baseline, the frequency of unprotected sex
    decreased in all three groups. This change was statistically
    significant in the SA and PA groups but not in the AP group
    (Decrease from 50% to 41% in PA, and from 53% to 41% in SA, p\< 0.01
    by McNemar's test; but from 49% to 47% in AP, p=NS).

***Table 6.* Sexual and Contraceptive Behaviors**

+------------------------+----------+----------+----------+----------+
| **Behavior**           | **Ph     | **A      | **St     | *        |
|                        | armacy** | dvance** | andard** | *Total** |
|                        |          |          |          |          |
|                        | **       | **Pro    | **       | *        |
|                        | Access** | vision** | Access** | *N=936** |
|                        |          |          |          |          |
|                        | *        | *        | *        |          |
|                        | *N=314** | *N=316** | *N=306** |          |
+------------------------+----------+----------+----------+----------+
| > **Unprotected        |          |          |          |          |
| > Intercourse**        |          |          |          |          |
+------------------------+----------+----------+----------+----------+
| > ***At Baseline (past |          |          |          |          |
| > 6 month)***          |          |          |          |          |
+------------------------+----------+----------+----------+----------+
| > Total                | > **156  | > **153  | > **162  | > 471    |
|                        | >        | >        | >        | > (50.4) |
|                        | (49.7)** | (48.6)** | (52.9)** |          |
+------------------------+----------+----------+----------+----------+
| > Every time           | > 12     | > 13     | > 12     | > 37     |
|                        | > (3.8)  | > (4.1)  | > (3.9)  | > (4.0)  |
+------------------------+----------+----------+----------+----------+
| > Most of the time     | > 18     | > 32     | > 25     | > 75     |
|                        | > (5.7)  | > (10.2) | > (8.2)  | > (8.0)  |
+------------------------+----------+----------+----------+----------+
| > Some of the time     | > 126    | > 108    | > 125    | > 359    |
|                        | > (40.1) | > (34.3) | > (40.9) | > (38.4) |
+------------------------+----------+----------+----------+----------+
| > Never                | > 158    | > 162    | > 144    | > 464    |
|                        | > (50.3) | > (51.4) | > (47.1) | > (49.6) |
+------------------------+----------+----------+----------+----------+
| > At last sex          | > 26     | > 32     | > 35     | > 93     |
|                        | > (8.3)  | > (10.1) | > (11.4) | > (9.9)  |
+------------------------+----------+----------+----------+----------+
| > ***At Follow-up(≥ 6  |          |          |          |          |
| > month)***            |          |          |          |          |
+------------------------+----------+----------+----------+----------+
| > Total                | > **127  | > **147  | > **124  | > 398    |
|                        | >        | >        | >        | > (42.6) |
|                        | (40.6)** | (46.7)** | (40.5)** |          |
+------------------------+----------+----------+----------+----------+
| > Every time           | > 9      | > 11     | > 7      | > 27     |
|                        | > (2.9)  | > (3.5)  | > (2.3)  | > (2.9)  |
+------------------------+----------+----------+----------+----------+
| > Most of the time     | > 16     | > 24     | > 22     | > 62     |
|                        | > (5.1)  | > (7.6)  | > (7.2)  | > (6.6)  |
+------------------------+----------+----------+----------+----------+
| > Some of the time     | > 102    | > 112    | > 95     | > 309    |
|                        | > (32.6) | > (35.6) | > (31.1) | > (33.1) |
+------------------------+----------+----------+----------+----------+
| > Never                | > 186    | > 168    | > 182    | > 536    |
|                        | > (59.4) | > (53.3) | > (59.5) | > (57.4) |
+------------------------+----------+----------+----------+----------+
| > At last sex          | > 30     | > 37     | > 24     | > 91     |
|                        | > (9.6)  | > (11.8) | > (7.9)  | > (9.7)  |
+------------------------+----------+----------+----------+----------+
| > **Condom Use**       |          |          |          |          |
+------------------------+----------+----------+----------+----------+
| > ***At Baseline (past |          |          |          |          |
| > 6 month)***          |          |          |          |          |
+------------------------+----------+----------+----------+----------+
| > Total                | > **257  | > **254  | > **248  | > 759    |
|                        | >        | >        | >        | > (81.2) |
|                        | (81.8)** | (80.4)** | (81.3)** |          |
+------------------------+----------+----------+----------+----------+
| > Every time           | > 87     | > 83     | > 75     | > 245    |
|                        | > (27.7) | > (26.3) | > (24.6) | > (26.2) |
+------------------------+----------+----------+----------+----------+
| > Most of the time     | > 86     | > 83     | > 86     | > 255    |
|                        | > (27.4) | > (26.3) | > (28.2) | > (27.3) |
+------------------------+----------+----------+----------+----------+
| > Some of the time     | > 84     | > 88     | > 87     | > 259    |
|                        | > (26.8) | > (27.9) | > (28.5) | > (27.7) |
+------------------------+----------+----------+----------+----------+
| > Never                | > 57     | > 62     | > 57     | > 176    |
|                        | > (18.2) | > (19.6) | > (18.7) | > (18.8) |
+------------------------+----------+----------+----------+----------+
| > Use at last sex      | > **190  | > **184  | > **174  | > 548    |
|                        | >        | >        | >        | > (58.6) |
|                        | (60.5)** | (58.2)** | (56.9)** |          |
+------------------------+----------+----------+----------+----------+
| > Currently using      | > 219    | > 214    | > 192    | > 625    |
|                        | > (69.8) | > (67.7) | > (62.8) | > (66.8) |
+------------------------+----------+----------+----------+----------+
| > ***At Follow-up(≥ 6  |          |          |          |          |
| > month)***            |          |          |          |          |
+------------------------+----------+----------+----------+----------+
| > Total                | > **226  | > **232  | > **224  | > 682    |
|                        | >        | >        | >        | > (73.5) |
|                        | (72.7)** | (74.4)** | (73.4)** |          |
+------------------------+----------+----------+----------+----------+
| > Every time           | > 84     | > 68     | > 78     | > 230    |
|                        | > (27.0) | > (21.8) | > (25.6) | > (24.8) |
+------------------------+----------+----------+----------+----------+
| > Most of the time     | > 77     | > 82     | > 75     | > 234    |
|                        | > (24.8) | > (26.3) | > (24.6) | > (25.2) |
+------------------------+----------+----------+----------+----------+
| > Some of the time     | > 65     | > 82     | > 71     | > 218    |
|                        | > (20.9) | > (26.3) | > (23.3) | > (23.5) |
+------------------------+----------+----------+----------+----------+
| > Never                | > 85     | > 80     | > 81     | > 246    |
|                        | > (27.3) | > (25.6) | > (26.6) | > (26.5) |
+------------------------+----------+----------+----------+----------+
| > Use at last sex      | > **159  | > **154  | > **170  | > 483    |
|                        | >        | >        | >        | > (51.7) |
|                        | (50.6)** | (48.9)** | (55.7)** |          |
+------------------------+----------+----------+----------+----------+
| > Currently using      | > 178    | > 179    | > 186    | > 543    |
|                        | > (56.7) | > (56.7) | > (60.8) | > (58.0) |
+------------------------+----------+----------+----------+----------+
| > **Oral Contraceptive |          |          |          |          |
| > Use**                |          |          |          |          |
+------------------------+----------+----------+----------+----------+
| > ***At Baseline (past |          |          |          |          |
| > 6 month)***          |          |          |          |          |
+------------------------+----------+----------+----------+----------+
| > Missing pill (per    | > 243    | > 74     | > 90     | > 79     |
| > pack)                | > (63.6) | > (58.3) | > (68.7) | > (63.7) |
+------------------------+----------+----------+----------+----------+
| > Use at last sex      | > 117    | > 125    | > 115    | > 357    |
|                        | > (37.3) | > (39.6) | > (37.6) | > (38.1) |
+------------------------+----------+----------+----------+----------+
| > Currently using      | > 129    | > 132    | > 125    | > 386    |
|                        | > (41.1) | > (41.8) | > (40.9) | > (41.2) |
+------------------------+----------+----------+----------+----------+
| > ***At Follow-up(≥ 6  |          |          |          |          |
| > month)***            |          |          |          |          |
+------------------------+----------+----------+----------+----------+
| > Missing pill (per    | > 276    | > 96     | > 97     | > 83     |
| > pack)                | > (68.0) | > (65.7) | > (70.3) | > (68.0) |
+------------------------+----------+----------+----------+----------+
| > Use at last sex      | > 159    | > 150    | > 141    | > 450    |
|                        | > (50.6) | > (47.8) | > (46.2) | > (48.2) |
+------------------------+----------+----------+----------+----------+
| > Currently using      | > 159    | > 150    | > 139    | > 448    |
|                        | > (50.6) | > (47.5) | > (45.4) | > (47.9) |
+------------------------+----------+----------+----------+----------+

Data were extracted and summarized from author's Table 6 (p8) and Table
9 (p11), presented as "No. (%)

***Contraception Methods (Table 6):***

There were no statistically significant differences in condom and OC
uses among the 3 groups during the study period.

1.  Overall condom use decreased in all 3 groups as compared with the
    baseline; condom use "at last sex" significantly decreased in the
    Advance Provision and the Pharmacy Access groups (P\< 0.01), but
    remained relatively stable in the Standard Access group (p\< 0.65).

2.  During the same period that condom use decreased, there were
    increase in "currently using" OC in all groups compared to the
    baseline. The "Use at last sex" increased in all groups (PA
    change=37% to 51%, AP change=40% to 48% and SA change=38% to 46%).

***Age difference:***

There were no significant differences in observed parameters (pregnancy,
condom use, unprotected sex, routine OC use) between adolescents (15-17
years old) and adults (18-24 years old).

**COMMENTS**

1.  The proportion of 15-17 year olds and the literacy level of subjects
    were not provided.

2.  "Baseline" STDs were reported, but the exposure period over which an
    infection was acquired was not captured. However, STDs acquired
    during the study among the 3 groups were comparable and were lower
    than the "baseline" history.

3.  Overall unprotected intercourse decreased in all three groups
    compared to baseline. This change was statistically significant in
    the SA and PA groups but not in the AP group (from 50% to 41% in PA,
    and from 53% to 41% in SA, p\< 0.01 by McNemar's test; but from 49%
    to 47% in PA, p=NS).

**SUMMARY**

1.  Advance Provision did not increase STDs as compared with the
    Pharmacy Access and the Standard Access to EC.

2.  Subjects in the Advance Provision group were more likely to use EC
    pills as compared to the Standard and Pharmacy Accesses.

3.  All three groups had less unprotected intercourse during the
    follow-up as compared to baseline. When compared to baseline, the PA
    and SA groups decreased more (P\<0.01) than the advance EC provision
    group (p=NS).

4.  All three EC accesses were associated with a decrease in condom use,
    with statistically significant decreased differences in "use at last
    use" among the Advance Provision and the Pharmacy Access groups.
    However, the decrease in condom use was offset with increased oral
    contraceptive use.

5.  Although there was greater OC use at study end compared to baseline
    for "use at last sex" and "currently using" in all 3 groups the
    proportion in all three groups who reported "missing OC pills" at
    study end compared to baseline increased.

**CONCLUSION**

Advance Provision of emergency contraception was not found to be
associated with a difference in pregnancy rates or acquired STDs
compared to Pharmacy Access or Standard Access. Advance Provision
decreased unprotected intercourse compared to baseline, but to less of
an extent that the Pharmacy Access or Standard Access groups. All three
groups had increased OC use and decreased condom use. All three groups
had increased "missing oral contraceptive pills" compared to baseline at
study end. The highest rate of unprotected sex was in the AP group (49%
vs. 41% in the PA & SA groups).

***Literature* #3** (sNDA 21-045, Serial No. 105, p5162)

**Advance Supply of Emergency Contraception: Effect on Use and Usual
Contraception---A Randomized Trial**

**Author:** Rebecca A. Jackson, Eleanor Bimla Schwarz, Lori Freedman,
and

> Philip Darney

**Affiliate:** Center for Reproductive Health Research and Policy and
Department of Obstetrics, Gynecology, and Reproductive Sciences, and
Division of General Internal Medicine

> Department of Medicine, UCSF, and San Francisco General Hospital, San
> Francisco, California.

**Sponsor:** Partially funded by an unrestricted grant from the Packard
Foundation. The Packard Foundation is a nonprofit organization.

> They provided funds for supplies and oral contraceptive pills.

**Study Location: *USA,*** a public inner-city hospital in San Francisco

> From September 1998 through March 1999

**Publication:** ***Obetet Gynecol*** 102: 8-16, 2003

**Design:** Randomized (by date of discharge) controlled clinical trial

> 1 year observation
>
> Single course of advance EC provision

**METHODS**

**Subject:** A total of 370 ***postpartum women*** were enrolled from a
public inner-city hospital (San Francisco, CA) from September 1998
through March 1999, with the following eligibility criteria:

> Age: (*was not specified in the Method*)
>
> Postpartum women (had a live birth)
>
> Spoke English or Spanish
>
> Available for follow-up in 1 year
>
> Had not undergone a postpartum tubal ligation

Subjects were randomly assigned to the following 2 groups:

***Advance Provision Group:*** 184 subjects received one course of EC
pills and EC education. The one course EC contained 8 oral contraceptive
pills containing 0.15 mg of levonorgestrel and 30 ug of ethinyl
estradiol. The educational session was a 5-minute intervention and
included instructions for obtaining additional emergency contraception
pills if needed.

***Control group:*** 186 subjects received only routine contraceptive
counseling, and this ***did not*** usually include EC education.

To prevent interference of the difference education's that provided to
each group, the investigators enrolled all women on a given day to the
same group.

**Data Collection:** A Kaiser Family Foundation Questionnaire (survey)
was the data collection instrument. The questionnaire was administered
in person at enrollment and by phone at 6 and 12 months. The primary
outcome was self-reported use of emergency contraception. Secondary
outcomes included change in use of other contraceptive methods and
knowledge about emergency contraception. Contraceptive and sexual
behaviors were assessed by asking about types of contraception used and
consistency of use.

**Data Analysis:** The individual subject was used as the unit of
analysis. Differences between groups and differences within each group
over time were analyzed using the Fisher exact test, Student *t* test,
or the McNemar test.

**RESULTS**

**Subject Demographics**

Of 721 screened subjects, 370 were enrolled and randomized to the
Advance EC group (184) and Control group (186). The demographics and
baseline characteristics of the enrolled subjects are summarized in
Table 1; there were no statistically significant differences between the
two groups. Approximately 18% were teens; 72% were Latina; 43% married.
About half had a high school education.

**Follow-up Compliance**

At 6 months after enrollment, follow-up was available for 78% and at 1
year, 69%. Overall, 85% were available for at least one follow-up
session. There were no differences between groups in the proportion lost
to follow-up; nor were there differences in baseline traits between
those lost to follow-up and those who completed the study (Table 1).

***Table 1.* Demographics and Baseline characteristics of enrolled
subjects**

(% of enrolled subjects)

+--------------------------------+------------------+-----------------+
| **Characteristic**             | **Advance EC**   | **Control**     |
+--------------------------------+------------------+-----------------+
|                                | **(*n* = 184)**  | **(n = 186)**   |
+--------------------------------+------------------+-----------------+
| > ***Age*** (mean ±SD),        | > 26 ± 6         | > 26 ± 6        |
| > *years*                      |                  |                 |
+--------------------------------+------------------+-----------------+
| > ***Ethnicity***              |                  |                 |
+--------------------------------+------------------+-----------------+
| > Hispanic                     | > 69             | > 74            |
+--------------------------------+------------------+-----------------+
| > Non-Hispanic black           | > 11             | > 11            |
+--------------------------------+------------------+-----------------+
| > Asian/Pacific islander       | > 10             | > 11            |
+--------------------------------+------------------+-----------------+
| > Non-Hispanic white           | > 9              | > 3             |
+--------------------------------+------------------+-----------------+
| > ***Education***              |                  |                 |
+--------------------------------+------------------+-----------------+
| > High school graduate         | > 47             | > 48            |
+--------------------------------+------------------+-----------------+
| > ***Employed***               | > 62             | > 53            |
+--------------------------------+------------------+-----------------+
| > ***Income \> \$20,000***     | > 11             | > 11            |
+--------------------------------+------------------+-----------------+
| > ***Private insurance***      | > 4              | > 2             |
+--------------------------------+------------------+-----------------+
| > ***Married***                | > 42             | > 45            |
+--------------------------------+------------------+-----------------+
| > ***Pregnancy history***      |                  |                 |
+--------------------------------+------------------+-----------------+
| > Multiparous                  | > 49             | > 48            |
+--------------------------------+------------------+-----------------+
| > Prior elective abortion(s)   | > 16             | > 18            |
+--------------------------------+------------------+-----------------+
| > Index pregnancy unplanned    | > 65             | > 64            |
+--------------------------------+------------------+-----------------+
| > Prior unwanted pregnancy     | > 39             | > 38            |
+--------------------------------+------------------+-----------------+
| > ***Lost to Follow-up***      |                  |                 |
+--------------------------------+------------------+-----------------+
| > At 6 months                  | > 25             | > 20            |
+--------------------------------+------------------+-----------------+
| > At 12 months                 | > 30             | > 31            |
+--------------------------------+------------------+-----------------+
| > Both 6 and 12 months         | > 17             | > 12            |
+--------------------------------+------------------+-----------------+

> Data were extracted from author's Table 1 and Figure 1.

**Sexual and Contraceptive Behavior**

Sexual and contraceptive behaviors of subjects during 6 month period
before and after enrollment in both groups were summarized in Tables 2
and 3.

***Unprotected sex:***

-   Half the women in both groups reported at least one episode of
    unprotected intercourse during the 1-year follow-up period with no
    significant differences between groups, although the proportion was
    somewhat lower on the EC arm.

***EC use:***

-   Women in the Advance EC provision group were significantly more
    likely to use ECPs during the study (13% vs 2% at one year).

-   Subjects in both groups became more knowledgeable about emergency
    contraception during study periods; the Advance group demonstrated
    the greatest increase in knowledge.

-   Five subjects used multiple doses of EC over the one year period,
    and three of them were in the Advance EC group.

-   Approximately 25% of the study subjects could state the correct
    timing for using EC pills, which was consistent with results (18%
    correct use) from another study (Endres et al: *Experience with
    self-administered emergency contraception in a low-income,
    inner-city family planning program. J Reprod Med 2000;45:827--30*).

***Condom use:***

Among exclusive condom users, there was an increase in the use routine
("use mostly or always") of condoms in both groups as compared to the
baseline. The proportion of routine condom use was similar between
groups at follow-up although the proportional increased from baseline
was greatest in the control group.

***Primary contraception:***

> As compared to baseline, there was a significant improvement in
> contraceptive use (more effective methods and consistency) in both
> groups during the 12-month follow-up, similar between groups.

**COMMENTS**

1.  The study population, postpartum women from an inner-city hospital,
    is not completely generalizable to the spectrum of sexually active
    women expected in an OTC setting.

2.  Only a single course of EC was provided to the Advance provision
    group, and few requested additional EC pills during the study.

3.  There were not observed differences between the Advance EC group
    compared to the control group regarding unprotected intercourse
    rates at 6 month and 12 months..

4.  Randomization procedure was by date of discharge was not ideal and
    the sample size was small (n=370). The majority of the study
    population was Latina postpartum women.

**CONCLUSION**

Advance EC access in the ***postpartum women*** during the 1-year
observation:

1.  Increases EC use

2.  Did not adversely change routine contraception, including condom
    use. The advance EC group maintained similar contraception use as
    the control group. Routine contraception use increased in Advance EC
    and Control groups.

3.  Did not increase the frequency of unprotected intercourse as
    compared to control subjects and over time.

***Table 2.* Use and knowledge of Emergency Contraception**

(% of subjects who provided data)

+---------------+------+----+------+----+-------+------+----+-------+
| **Outcome**   | **Ba |    | **At |    |       | **At |    |       |
|               | seli |    | 6    |    |       | 12   |    |       |
|               | ne** |    | mont |    |       | mont |    |       |
|               |      |    | hs** |    |       | hs** |    |       |
+---------------+------+----+------+----+-------+------+----+-------+
|               | *    | *  | *    | *  | *     | *    | *  | *     |
|               | *Adv | *C | *Adv | *C | *RR** | *Adv | *C | *RR** |
|               | ance | on | ance | on |       | ance | on |       |
|               | EC** | tr | EC** | tr | *     | EC** | tr | *     |
|               |      | ol |      | ol | *(95% |      | ol | *(95% |
|               | *    | ** | *    | ** | CI)** | *    | ** | CI)** |
|               | *N=1 |    | *N=1 |    |       | *N=1 |    |       |
|               | 84** | *  | 38** | *  |       | 28** | *  |       |
|               |      | *N |      | *N |       |      | *N |       |
|               |      | =1 |      | =1 |       |      | =1 |       |
|               |      | 86 |      | 49 |       |      | 28 |       |
|               |      | ** |      | ** |       |      | ** |       |
+---------------+------+----+------+----+-------+------+----+-------+
| ***Use of EC  |      |    |      |    |       |      |    |       |
| in prior 6    |      |    |      |    |       |      |    |       |
| months***     |      |    |      |    |       |      |    |       |
+---------------+------+----+------+----+-------+------+----+-------+
| > Use at      | > 3  | >  | > 10 | >  | 3.56  | > 13 | >  | 5.21  |
| > least once  |      |  3 |      |  3 | (     |      |  2 | (     |
|               |      |    |      |    | 1.19, |      |    | 1.55, |
|               |      |    |      |    | 10.7) |      |    | 17.5) |
+---------------+------+----+------+----+-------+------+----+-------+
| > New users   |      |    | > 8  | >  | 6.03  | > 10 | >  | 4.17  |
| > of EC       |      |    |      |  1 | (     |      |  2 | (     |
|               |      |    |      |    | 1.36, |      |    | 1.21, |
|               |      |    |      |    | 26.7) |      |    | 14.4) |
+---------------+------+----+------+----+-------+------+----+-------+
| > In those    |      |    | > 22 | >  | 7.74  | > 16 | >  | 5.14  |
| > with any    |      |    |      |  3 | (     |      |  3 | (     |
| > unprotected |      |    |      |    | 1.81, |      |    | 1.14, |
| > intercourse |      |    |      |    | 33.2) |      |    | 23.1) |
+---------------+------+----+------+----+-------+------+----+-------+
| ***General EC |      |    |      |    |       |      |    |       |
| knowledge†*** |      |    |      |    |       |      |    |       |
+---------------+------+----+------+----+-------+------+----+-------+
| > Has heard   | > 34 | >  | > 90 | >  | 1.91  | > 91 | >  | 1.31  |
| > of "EC" or  |      | 38 |      | 47 | (     |      | 70 | (     |
| > "MAP"       |      |    |      |    | 1.59, |      |    | 1.16, |
|               |      |    |      |    | 2.29) |      |    | 1.49) |
+---------------+------+----+------+----+-------+------+----+-------+
| > Salient     | > 18 | >  | > 70 | >  | 2.14  | > 71 | >  | 1.38  |
| > knowledge   |      | 20 |      | 32 | (     |      | 52 | (     |
| > about EC    |      |    |      |    | 1.66, |      |    | 1.13, |
|               |      |    |      |    | 2.77) |      |    | 1.69) |
+---------------+------+----+------+----+-------+------+----+-------+

Data were extracted from author's Table 2.

† "Heard of EC" indicates familiarity with the name "emergency
contraception" or "morning-after pill." "Salient knowledge" indicates
the subject was able to correctly name or describe EC pills.

***Table 3.* Changes in contraceptive behavior**

(% of subjects who provided data)

+---------------+------+----+------+----+-------+------+----+-------+
| **Outcome**   | **Ba |    | **At |    |       | **At |    |       |
|               | seli |    | 6    |    |       | 12   |    |       |
|               | ne** |    | mont |    |       | mont |    |       |
|               |      |    | hs** |    |       | hs** |    |       |
+---------------+------+----+------+----+-------+------+----+-------+
|               | *    | *  | *    | *  | *     | *    | *  | *     |
|               | *Adv | *C | *Adv | *C | *RR** | *Adv | *C | *RR** |
|               | ance | on | ance | on |       | ance | on |       |
|               | EC** | tr | EC** | tr | *     | EC** | tr | *     |
|               |      | ol |      | ol | *(95% |      | ol | *(95% |
|               | *    | ** | *    | ** | CI)** | *    | ** | CI)** |
|               | *N=1 |    | *N=1 |    |       | *N=1 |    |       |
|               | 84** | *  | 36** | *  |       | 20** | *  |       |
|               |      | *N |      | *N |       |      | *N |       |
|               |      | =1 |      | =1 |       |      | =1 |       |
|               |      | 86 |      | 49 |       |      | 25 |       |
|               |      | ** |      | ** |       |      | ** |       |
+---------------+------+----+------+----+-------+------+----+-------+
| *             |      |    |      |    |       |      |    |       |
| **Consistency |      |    |      |    |       |      |    |       |
| of            |      |    |      |    |       |      |    |       |
| contraceptive |      |    |      |    |       |      |    |       |
| use***        |      |    |      |    |       |      |    |       |
+---------------+------+----+------+----+-------+------+----+-------+
| > Routine use | > 35 | >  | > 85 | >  | 1.02  | > 83 | >  | 1.02  |
| > of          |      | 37 |      | 83 | (     |      | 81 | (     |
| >             |      |    |      |    | 0.92, |      |    | 0.91, |
| contraception |      |    |      |    | 1.12) |      |    | 1.15) |
+---------------+------+----+------+----+-------+------+----+-------+
| > Less        |      |    | > 8  | >  | 0.60  | > 18 | >  | 0.74  |
| > consistent  |      |    |      | 13 | (     |      | 25 | (     |
| > use         |      |    |      |    | 0.30, |      |    | 0.45, |
| > compared    |      |    |      |    | 1.21) |      |    | 1.20) |
| > with prior  |      |    |      |    |       |      |    |       |
| > 6 mo        |      |    |      |    |       |      |    |       |
+---------------+------+----+------+----+-------+------+----+-------+
| > Any         | >    | >  | > ** | >  | 0.91  | > ** | >  | 0.87  |
| > unprotected |  ?\* |  ? | 47** | ** | (     | 47** | ** | (     |
| > intercourse |      | \* |      | 52 | 0.71, |      | 54 | 0.67, |
|               |      |    |      | ** | 1.17) |      | ** | 1.13) |
+---------------+------+----+------+----+-------+------+----+-------+
| > Routine use | > ** | >  | > ** | >  | 1.02  | > ** | >  | 0.94  |
| > of condoms  | 43** | ** | 76** | ** | (     | 87** | ** | (     |
| > in          |      | 28 |      | 75 | 0.79, |      | 92 | 0.80, |
| > exclusive   |      | ** |      | ** | 1.31) |      | ** | 1.12) |
| > condom      |      |    |      |    |       |      |    |       |
| > users^‡^    |      |    |      |    |       |      |    |       |
+---------------+------+----+------+----+-------+------+----+-------+
| ***           |      |    |      |    |       |      |    |       |
| Effectiveness |      |    |      |    |       |      |    |       |
| of            |      |    |      |    |       |      |    |       |
| contraceptive |      |    |      |    |       |      |    |       |
| method ^§^*** |      |    |      |    |       |      |    |       |
+---------------+------+----+------+----+-------+------+----+-------+
| > Very (\< 5% | > 56 | >  | > 71 | >  | 1.01  | > 70 | >  | 1.04  |
| > failure)    |      | 57 |      | 70 | (     |      | 67 | (     |
|               |      |    |      |    | 0.87, |      |    | 0.88, |
|               |      |    |      |    | 1.18) |      |    | 1.23) |
+---------------+------+----+------+----+-------+------+----+-------+
| > Poor (\>    | > 44 | >  | > 29 | >  | 0.97  | > 30 | >  | 0.92  |
| > 10%         |      | 43 |      | 30 | (     |      | 33 | (     |
| > failure)    |      |    |      |    | 0.68, |      |    | 0.63, |
|               |      |    |      |    | 1.38) |      |    | 1.33) |
+---------------+------+----+------+----+-------+------+----+-------+
| > Less        |      |    | > 18 | >  | 0.79  | > 21 | >  | 1.02  |
| > effective   |      |    |      | 22 | (     |      | 20 | (     |
| > method      |      |    |      |    | 0.50, |      |    | 0.62, |
| > compared    |      |    |      |    | 1.27) |      |    | 1.67) |
| > with prior  |      |    |      |    |       |      |    |       |
| > 6 mo        |      |    |      |    |       |      |    |       |
+---------------+------+----+------+----+-------+------+----+-------+

^§^ Very effective methods: sterilization, intrauterine device, depot
medroxyprogesterone acetate, levonorgestrel implants, and oral
contraceptives. Poorly effective methods: barrier, withdrawal, rhythm,
and none.

‡ Condom use mostly or always in those who use only condoms. Numbers in
EC and control at baseline, respectively: n = 54, 53; at 6 months: n =
38, 40; at 12 months: n = 31, 36; *however, calculation of the
percentages on this event in the Table was not specified in the report*.

\* The frequency of unprotected intercourse at baseline was not
reported.

***Literature* #4** (vol. 13, page 007; Abstract)

**Advanced supply of emergency contraception for adolescent mothers
increased utilization without reducing condom or primary contraction
use**

**Author:** Marvin Belzer, Elizabeth Yoshida, Talar Tejirian, Diane
Tucker, Katie Chung, Kathleen Sanchez

**Affiliate:** Children's Hospital Los Angeles, Los Angeles, California

**Sponsor:** Unknown

**Study Location: *USA,*** a large urban city (LA, California)

(Unknown site)

**Publication:** ***J Adolescent Health*** 32 (2): 5086 (Abstract only),
2003

**Design:** Randomized, 2-arm, single center trial

6-month follow-up

Single course of advance EC provision

**METHODS**

**Subject**

***Adolescent mothers*** were recruited and enrolled from a large urban
city (location and sites were not specified), age 14--20 years and not
desiring pregnancy. Exclusion criteria were not reported. The subjects
were randomized into the following 2 groups:

***Treatment groups:*** subjects received ***an advance supply*** of
levonorgestrel-only EC;

***Control group:*** subjects received education on emergency
contraception alone.

**Data Collection**

Subjects were contacted by phone at 6 months to collect the following
data with a questionnaire: hormonal contraception use, condom use,
sexual activity, unprotected sex, EC use, reasons for not using EC and
pregnancy.

**Data Analysis**

Chi-square tests were conducted to assess differences between groups.
Odds ratio and 95% CI were calculated to determine the association
between contraceptive use and group assignment at baseline and
follow-up.

**RESULTS**

**Subject Demographics and Follow-up compliance**

A total of 160 ***adolescent mothers*** were enrolled (number of
screened subjects was not provided); their compliance with follow-up
contacts at 6^th^ and 12^th^ month after enrollment is summarized in
Table 1.

***Table 1.* Subject enrollment and follow-up compliance**

+--------------------+---------------+---------------+---------------+
| **Subject**        | **Treatment** | **Control**   | **Total**     |
+--------------------+---------------+---------------+---------------+
| Enrollment         | > 82          | > 78          | > 160         |
+--------------------+---------------+---------------+---------------+
| 6^th^ month        | > 57          | > 54          | > 110 (69%)\* |
| follow-up          |               |               |               |
+--------------------+---------------+---------------+---------------+
| 12^th^ month       | > 42          | > 46          | > 88 (55%)\*  |
| follow-up          |               |               |               |
+--------------------+---------------+---------------+---------------+

> \* % of enrolled subjects.

***Demographics:***

> Mean age: 14-20 years
>
> Hispanic: 83%
>
> African American: 16%
>
> Education: unknown

**Changes in Contraceptive Behavior**

There were limited data available in the abstract about sexual and
contraceptive behavior at baseline and follow-up (6^th^ and 12^th^
month) from both groups. Table 2 was extracted from text of the
abstract.

***Unprotected sex:*** The author stated that there were no increases in
unprotected sex in the treatment group; but no data were provided.

***EC use:*** Subjects in the treatment group were more likely to use
EC.

***Condom use:*** The author stated that there were no changes in condom
use at 6^th^ month between treatment and control groups, but no data
were provided.

***Primary contraception:*** The author stated that there were no
changes in primary contraception at 6^th^ month between 2 groups, but no
data were provided.

***Table 2.* Sexual and contraceptive behavior**

+-------------------+-------------------+---------------+-------------+
|                   | **Treatment**     | **Control**   | **Total**   |
|                   |                   |               |             |
|                   | ***One package    | ***Education  | **N=111**   |
|                   | EC***             | only***       |             |
|                   |                   |               |             |
|                   | **N=57**          | **N=54**      |             |
+-------------------+-------------------+---------------+-------------+
| ***Sexually       |                   |               |             |
| active***         |                   |               |             |
+-------------------+-------------------+---------------+-------------+
| > Baseline        | > ND              | > ND          | > 59%       |
+-------------------+-------------------+---------------+-------------+
| > At 6^th^ month  | > 62%             | > 57%         |             |
+-------------------+-------------------+---------------+-------------+
| ***Unprotected    |                   |               |             |
| sex***            |                   |               |             |
+-------------------+-------------------+---------------+-------------+
| > Baseline        |                   |               | > 7%        |
+-------------------+-------------------+---------------+-------------+
| > At 6^th^ month  | > ND              | > ND          | > No change |
+-------------------+-------------------+---------------+-------------+
| ***EC Use\****    |                   |               |             |
+-------------------+-------------------+---------------+-------------+
| > At 6^th^ month  | > 85%             | > 19%         |             |
+-------------------+-------------------+---------------+-------------+
| > At 12^th^ month | > 79%             | > 21%         |             |
+-------------------+-------------------+---------------+-------------+
| Pregnancies at    | > 4 (7%)          | > 10 (18%)    |             |
| 6^th^ month       |                   |               |             |
+-------------------+-------------------+---------------+-------------+
| Change in primary | OR = 0.77 Between |               |             |
| contraception     | group comparison  |               |             |
|                   |                   |               |             |
|                   | (95% CI:          |               |             |
|                   | 0.47-1.25)        |               |             |
+-------------------+-------------------+---------------+-------------+
| Change in condom  | OR = 0.71 Between |               |             |
| use               | group comparison  |               |             |
|                   |                   |               |             |
|                   | (95% CI:          |               |             |
|                   | 0.32-1.57)        |               |             |
+-------------------+-------------------+---------------+-------------+

> ND: no data were reported in the abstract.
>
> \* % of subjects who had unprotected sex.

**COMMENTS**

1.  There were limited data provided on primary parameters to evaluate
    changes of interest, particularly condom use and unprotected sex.

2.  Subjects were adolescent mothers and may have limited
    generalizability to the OTC setting.

3.  Only a single course of EC was provided to the advance provision
    group, which did not reflect access in an OTC setting.

4.  Small study size may have led to lack of observed statistically
    significant differences.

**CONCLUSION**

Advance EC provision was reported not to decrease condom use and primary
contraception during the 6-month follow-up.

***Literature* #5** (vol 13, page 023)

**The Effects of Advance Provision of Emergency Contraception on
Adolescent Women\'s Sexual and Contraceptive Behaviors**

**Author:** Melanie A. Gold

**Affiliate:** University of Pittsburgh School of Medicine

> Children\'s Hospital of Pittsburgh, Division of Adolescent Medicine

**Sponsor:** Laurel Foundation (unknown location) for financial support.

> Woman's Capital Corporation provided Plan B.

**Study Location: *USA,*** an urban hospital-based adolescent clinic

> Pittsburgh, PA from June 1997 to June 2002.

**Publication:** Unpublished Manuscript

**Design:** Single-center, randomized clinical trial

8 months follow-up

Single course of advance EC provision

**METHODS**

**Subject**

Sexually active female adolescents were recruited from the waiting room
of an urban hospital-based adolescent clinic in a Children's Hospital in
southwestern Pennsylvania between June 1997 and October 2001, with the
following criteria:

> ***Inclusion criteria:***
>
> Age 15--20 years
>
> Available for monthly follow-up by phone.
>
> ***Exclusion criteria:***
>
> Live in a foster-care or group home setting
>
> Using long-acting contraception (such as IUD, Norplant, Depo-Provera)
>
> OC users were not excluded.

Of 779 screened adolescent women, 301 (39%) were enrolled and randomly
assigned to the following 2 groups:

***Advance EC group:*** 150 subjects received EC education information
and one course of EC pills, and were informed that they could obtain up
to 2 additional EC courses during 6 months. Yuzpe (Jun 1997 -- March
2000) and Plan B (after March 2000) were used.

***Control group:*** 151 subjects received EC education information and
were told how to request EC from the adolescent clinic (the same regimen
as the Advance EC) if/when needed.

**Data Collection**

Self-reported sexual, contraceptive behavior, pregnancy, STDs and EC use
for the past month and at last episode of intercourse were collected
monthly by telephone interview for 6 months after enrollment. At least 5
attempts were made to reach each subject for monthly interview. EC
knowledge was assessed at month 1 and 6 interviews only.

**RESULTS**

**Subject Demographics**

The following are major demographic characteristics. They were
comparable between the 2 groups.

> Mean age: 17.1 ± 1.7 years.
>
> Race: 57% African-American (45% used public Medical Assistance for
> health care insurance coverage); 30% white.
>
> Pregnancy history: 20%
>
> STD history: 30%
>
> Education: 59% high school (*not specified "in" or "completed"*)
>
> 28% college/trade school.
>
> Contraception: 73% condom use; 69% aware of EC.

**Compliance of follow-up**

Approximately 85% of enrolled subjects at month 1 and 65% at month 6
were interviewed. The median length of follow-up was 252 ± 32 days from
enrollment. The follow-up compliance between the 2 groups was
comparable.

**Changes in Sexual and Contraceptive Behaviors**

Sexual and contraceptive behaviors of subjects from the Advance EC and
control groups at the 1^st^ and 6^th^ month after enrollment are
summarized in Table 1. In the original Table, the author did not
indicate how the percentages were calculated. Therefore, this reviewer
compiled the data from the original table using the number of subjects
who completed interview as a denominator (Table 1). The trends of the
results are similar to the original presentation. At study entry 20% of
subjects had a history of pregnancy, 30% had a history of STD, and 69%
reported awareness of EC. Twenty-five percent reported their last
intercourse was unprotected, 73% reported condom use and 38% reported OC
use.

***Table 1.* Sexual and contraceptive Behaviors**

\[*No. (% of subjects who completed interview)*\]

+--------------------+-----------+-----------+-----------+-----------+
| **Behavior**       | **First   |           | **Sixth   |           |
|                    | Month     |           | Month     |           |
|                    | Fo        |           | Fo        |           |
|                    | llow-up** |           | llow-up** |           |
+--------------------+-----------+-----------+-----------+-----------+
|                    | **Advance | **        | **Advance | **        |
|                    | EC**      | Control** | EC**      | Control** |
+--------------------+-----------+-----------+-----------+-----------+
| ***Enrolled        | > 150     | > 151     | > 150     | > 151     |
| Subjects†***       |           |           |           |           |
+--------------------+-----------+-----------+-----------+-----------+
| ***Completed       | > 123     | > 131     | > 91 (61) | > 105     |
| Interview†***      | > (82)    | > (87)    |           | > (70)    |
+--------------------+-----------+-----------+-----------+-----------+
| ***EC Use‡***      | \(15\)    | \(8\)     | \(8\)     | \(6\)     |
+--------------------+-----------+-----------+-----------+-----------+
| ***STDs‡***        |           |           | > 12 (13) | > 12 (11) |
+--------------------+-----------+-----------+-----------+-----------+
| ***In past         |           |           |           |           |
| month***           |           |           |           |           |
+--------------------+-----------+-----------+-----------+-----------+
| > Unprotected      | > 24 (20) | > 28 (21) | > 16 (18) | > 19 (18) |
| > intercourse      |           |           |           |           |
+--------------------+-----------+-----------+-----------+-----------+
| > Used condom      | > 73 (59) | > 85 (65) | > 70 (77) | > 65 (62) |
+--------------------+-----------+-----------+-----------+-----------+
| > Used OC pills    | > 42 (34) | > 51 (39) | > 33 (36) | > 50 (48) |
+--------------------+-----------+-----------+-----------+-----------+
| > Used any         | > 42 (34) | > 51 (39) | > 40 (44) | > 56 (53) |
| > hormonal         |           |           |           |           |
| > contraception    |           |           |           |           |
+--------------------+-----------+-----------+-----------+-----------+
| ***At last         |           |           |           |           |
| intercourse***     |           |           |           |           |
+--------------------+-----------+-----------+-----------+-----------+
| > Unprotected      | > 21 (17) | > 25 (19) | > 10 (11) | > 19 (18) |
+--------------------+-----------+-----------+-----------+-----------+
| > Used condom      | > 70 (57) | > 80 (61) | > 67 (74) | > 66 (63) |
+--------------------+-----------+-----------+-----------+-----------+
| > Used OC pills    | > 35 (28) | > 41 (31) | > 34 (37) | > 46 (44) |
+--------------------+-----------+-----------+-----------+-----------+
| > Used any         | > 35 (28) | > 41 (31) | > 39 (43) | > 50 (48) |
| > hormonal         |           |           |           |           |
| > contraception    |           |           |           |           |
+--------------------+-----------+-----------+-----------+-----------+

Data were extracted from the author's Table 2, or Figure A (**†)** or
text (**‡)**.

The denominators used for percentage calculation was not defined in
original Table, nor indicated in the report. The percentages in this
table were recalculated using number of subjects who completed interview
as a denominator.

***EC Use:***

At the first month, Advance EC group used EC more than control group
(15% vs. 8%, p=0.05); there was no difference between the 2 groups at
the 6^th^ month. In multivariate analysis the only independent variable
that predicted EC use was past pregnancy.

During the entire study, 22 subjects (15%) in the Advance EC group
returned to request extra course of EC (17 returned once, 4 twice, and
one 3 times). The Advance EC group reported more rapid first dose
administration compared to the control group- 11 hours vrs 22 hours
(p\<0.005).

***Unprotected Sex:***

At both the first and sixth month, there were not differences in
unprotected intercourse recorded for "in past month" or "at last
intercourse" between Advance EC and control groups. The proportion for
both arms at month 1 and 6 were slightly lower than the baseline rate of
unprotected intercourse, 25% on the Advanced EC arm and 24% on the
control arm.

***Contraception:***

There were no significant differences in condom use, OC pill use or
injectable contraceptive methods between Advance EC and control groups
at one month. The proportion of EC subjects who reported condom use, 59%
decreased from the baseline 76%. At 6 months a higher proportion of EC
subjects reported use of condoms, 77%, than the control, 62% (p=0.02).
At 6 months the proportion of EC subjects reporting condom use had
returned to the baseline level. Over the course of the study, there were
13 (9%) pregnancies reported by the advance therapy group compared to 18
(11%) pregnancies reported by the control group.

***STDs***

There were 12 subjects each in the Advance EC and control groups who
reported a newly-diagnosed STD during the study. By using number of
subjects who completed interview as a denominator, 10% of subjects in
the Advance EC group acquired STDs, compared to 9%.

**COMMENTS**

1.  Data process and analysis were not clearly presented.

2.  Only one course of EC was provided. Although the subjects could
    obtain an additional 2 courses, few subjects returned for additional
    request.

3.  Subjects were interviewed monthly; however, only data from months 1
    and 6 were reported.

4.  About 50% of eligible women declined to participate in the study due
    to "lack of interest".

5.  Comparisons between months 1 and 6 should be made with caution due
    to high attrition rate in both groups at month 6.

**CONCLUSION**

Advance provision of EC did not increase frequency of unprotected
intercourse and did not decrease condom use during the 6-month follow-up
in women ages 15-20 compared to a control group.

***Literature* #6** (vol 13, page 012)

**The Effects of Self-Administering Emergency Contraception**

**Author:** Anna Glasier and David Baird

**Affiliate:** Edinburgh Healthcare National Health Service Trust Family

> Planning and Well Woman Services
>
> Department of Obstetrics and Gynaecology
>
> University of Edinburgh, Scotland. United Kingdom.

**Financial Support:** Chief Scientist's Office

> Scottish Home and Health Department.

**Study Location: UK,** Family planning clinic and hospital in Edinburgh

From Jan 1994 to Dec 1996

**Publication:** ***New Eng J Med*** 339 (1): 1-4, 1998

**Design:** Randomized clinical trial, randomized by birthdate

1-year follow-up

> Single course of advanced EC provision

**METHODS**

**Subject**

A total of 1083 women, ages 16-44, were recruited from a family-planning
clinic and a large hospital in Edinburgh (Scotland, UK) between January
1994 and December 1996; 60% (650) were returning for follow-up of prior
EC consultations and 40% (433) were returning for follow-up after
therapeutic abortion.

Subjects were randomly assigned into the following 2 groups (on the
basis of their birthday (even-numbered birthdays were assigned to the
treatment group):

***Treatment group:*** 553 women received one package of EC pills (four
pills, each contained 50 µg of ethinyl estradiol and 0.25 mg of
levonorgestrel), written instructions and telephone numbers to call with
questions.

***Control group:*** 530 women received EC education and informed where
to get and how to use emergency contraception.

**Data Collection**

A questionnaire was sent to subjects ***one year*** after enrollment to
collect information about EC use, other contraception methods, and
pregnancy. If EC was used subjects were to mail in a notification card
with time of administration relative to intercourse and date of last
menstrual period. They were also instructed to go to the clinic within
one week after the date of expected menstrual period. At that time she
was given a replacement packet.

**Data Analysis**

Differences between the groups were tested by chi-square tests with
Yates' correction for binary factors or Mann--Whitney tests for ordinal
factors.

**RESULTS**

**Subject Demographics**

Only age and education of subjects were reported (Table 1). Twenty-three
percent of subjects were age \< 20 years old. Comparability of the UK
educational levels to the US system is unknown; but the author stated in
the report, approximately 50% of subjects had gone to a university or
college and \<20% had left school before age 16.

***Table 1.* Demographics and follow-up compliance of subjects**

\[No. (% of enrolled subjects)\]

+----------------------------+--------------------+-------------------+
| **Variable**               | **Treatment        | **Control Group** |
|                            | Group**            |                   |
+----------------------------+--------------------+-------------------+
| > ***Enrolled Subjects***  | > ***553***        | > ***530***       |
+----------------------------+--------------------+-------------------+
| > Recruited after EC use   | > 323 (58)         | > 327 (62)        |
+----------------------------+--------------------+-------------------+
| > Recruited after abortion | > 230 (42)         | > 203 (38)        |
+----------------------------+--------------------+-------------------+
| > Lost to Follow-up        | > 34 (6)           | > 44 (8)          |
+----------------------------+--------------------+-------------------+
| > ***Subjects with results | > ***549 (99)***   | > ***522 (98)***  |
| > available for            |                    |                   |
| > analysis***              |                    |                   |
+----------------------------+--------------------+-------------------+
| > ***Age (years)***        |                    |                   |
+----------------------------+--------------------+-------------------+
| > \<20                     | > 132 (24)         | > 116 (22)        |
+----------------------------+--------------------+-------------------+
| > 20--29                   | > 314 (57)         | > 309 (58)        |
+----------------------------+--------------------+-------------------+
| > \>30                     | > 107 (19)         | > 105 (20)        |
+----------------------------+--------------------+-------------------+
| > ***Education***          |                    |                   |
+----------------------------+--------------------+-------------------+
| > Age full-time education  |                    |                   |
| > ended                    |                    |                   |
+----------------------------+--------------------+-------------------+
| > \< 16 yr                 | > 93 (17)          | > 92 (17)         |
+----------------------------+--------------------+-------------------+
| > 17--18 yr                | > 127 (23)         | > 106 (20)        |
+----------------------------+--------------------+-------------------+
| > 19--22 yr                | > 116 (21)         | > 114 (22)        |
+----------------------------+--------------------+-------------------+
| > ≥ 23 yr                  | > 54 (10)          | > 61 (12)         |
+----------------------------+--------------------+-------------------+
| > Still in school full     | > 154 (28)         | > 145 (27)        |
| > time                     |                    |                   |
+----------------------------+--------------------+-------------------+
| > Educational status       | > 9 (2)            | > 12 (2)          |
| > unknown                  |                    |                   |
+----------------------------+--------------------+-------------------+

> Data were extracted from the author's Table 1.

**Follow-up Compliance**

Approximately 98% of subjects had data available for analysis of
pregnancy at the one-year follow-up. Ascertainment methods included
contacting the family doctor and the Scottish Health Department.
However, only 64% the subjects in both groups (350 of 549 in the
treatment group and 336 of 522 in the control group) were used for the
final analyses of sexual and contraceptive behaviors because they
provided the responses to the detailed questionnaire.

**Changes in Contraceptive Behavior:**

Sexual and contraceptive behaviors of subjects from treatment and
control groups at the enrollment and one-year follow-up are summarized
in Table 2.

***EC Use***:

> Women in the advance EC group were more likely to use emergency
> contraceptives than those in control groups; 47% used EC at least once
> in the treatment group vs. 27% in the control group at the one year
> follow-up. The difference in single use between groups (36% vs. 14%)
> was statistically significant (P\<0.01).
>
> The proportion of subjects in each arm who were recruited after prior
> use of EC was 58% in the treatment group and 62% in the control group.
> Comparison of multiple users was not statistically different between
> treatment and control groups.

***Condom Use***:

> Condom uses similarly decreased in both arms. Condom use decreased
> from 74% at baseline to 31% at one year in the treatment group and
> from 70% at baseline to 28% at one year in the control group.

***Contraception Methods***

> The proportion of oral contraception use increased similarly in both
> groups.

***Unprotected Sex***:

> Data on unprotected sex were not provided in the report. The "None
> contraception" shown in Table 2, which may include unprotected sex,
> decreased in both group at one year follow-up.

***Table 2.* Contraceptive behavior of subjects at enrollment and one
year later**

\[No. (% of subjects who provided contraception data)\]

+-------------------+------------+-----------+-----------+-----------+
| **Contraceptive   | *          |           | **Control |           |
| Behavior**        | *Treatment |           | group**   |           |
|                   | Group**    |           |           |           |
|                   |            |           | **        |           |
|                   | *          |           | N=336\*** |           |
|                   | *N=350\*** |           |           |           |
+-------------------+------------+-----------+-----------+-----------+
|                   | **At       | **One     | **At      | **One     |
|                   | En         | Year      | Enr       | Year      |
|                   | rollment** | Later**   | ollment** | Later**   |
+-------------------+------------+-----------+-----------+-----------+
| >                 |            |           |           |           |
|  ***Contraception |            |           |           |           |
| > Methods***      |            |           |           |           |
+-------------------+------------+-----------+-----------+-----------+
| > Oral            | > 45 (13)  | > 169     | > 46 (14) | > 171     |
| > contraception   |            | > (48)    |           | > (51)    |
+-------------------+------------+-----------+-----------+-----------+
| > Condom          | > ***258   | > ***108  | > ***235  | > ***94   |
|                   | > (74)***  | > (31)*** | > (70)*** | > (28)*** |
+-------------------+------------+-----------+-----------+-----------+
| > Diaphragm       | > 7 (2)    | > 7 (2)   | > 11 (3)  | > 15 (4)  |
+-------------------+------------+-----------+-----------+-----------+
| > Combination     | > 3 (1)    | > 31 (9)  | > 6 (2)   | > 34 (10) |
+-------------------+------------+-----------+-----------+-----------+
| > None            | > 34 (10)  | > 21 (6)  | > 33 (10) | > 15 (4)  |
+-------------------+------------+-----------+-----------+-----------+
| > Other or no     | > 3 (1)    | > 12 (3)  | > 5 (1)   | > 6 (2)   |
| > answer          |            |           |           |           |
+-------------------+------------+-----------+-----------+-----------+
| > ***EC Use†***   |            |           |           |           |
+-------------------+------------+-----------+-----------+-----------+
| > Did not use     |            | > 199     |           | > 239     |
|                   |            | > (53)    |           | > (73)    |
+-------------------+------------+-----------+-----------+-----------+
| > Used once       |            | > ***135  |           | > ***45   |
|                   |            | > (36)*** |           | > (1      |
|                   |            |           |           | 4)^\#^*** |
+-------------------+------------+-----------+-----------+-----------+
| > Used twice      |            | > 27 (7)  |           | > 33 (10) |
+-------------------+------------+-----------+-----------+-----------+
| > Used 3 times    |            | > 13 (3)  |           | > 8 (2)   |
+-------------------+------------+-----------+-----------+-----------+
| > Used \> 3 times |            | > 5 (1)   |           | > 1 (\<1) |
+-------------------+------------+-----------+-----------+-----------+
| >                 |            |           |           |           |
|  ***Pregnancy‡*** |            |           |           |           |
+-------------------+------------+-----------+-----------+-----------+
| > Total           |            | > 28 (5)  |           | > 33 (6)  |
| > Pregnancies     |            |           |           |           |
+-------------------+------------+-----------+-----------+-----------+
| > Unintended      |            | > 18 (3)  |           | > 25 (5)  |
| > Pregnancies     |            |           |           |           |
+-------------------+------------+-----------+-----------+-----------+
| > Abortions       |            | > 15 (3)  |           | > 19 (4)  |
+-------------------+------------+-----------+-----------+-----------+

\* The number of subjects who responded to the question regarding the
method of contraception.

† Percentage was calculated based on the subjects who provided data, 379
in the Treatment group and 326 in Control group.

‡ Percentage was calculated based on the subjects who provided data, 549
in the Treatment group and 522 in the Control group.

***^\#^*** P \< 0.001

**COMMENTS**

1.  The study population may not represent an OTC setting in US.
    Subjects were recruited from UK clinics (60% of them previously used
    emergency contraception and 40% had an abortion). Half of the
    subjects went to college/university.

2.  Only 64% of enrolled subjects provided data for analysis.

3.  A single course of EC was provided to the subjects in the advance EC
    provision group but they could return for further Advance Provisions
    after use of the single course.

**CONCLUSION**

1.  Women with advance EC access were more likely to use EC, and had
    lower frequency of "none" method of contraception compared to
    baseline at one year. The control group had a greater decrease in
    "none" method of contraception at one year compared to baseline than
    the advance EC group.

2.  Although 135 (36%) of the treatment group used the advance supply of
    EC, only about half returned for subsequent provisions of advanced
    supplies.

3.  Oral contraception use increased in both groups and condom use
    decreased in both group compared to baseline.

***Literature* #7** (vol 13, page 067a)

**Provision of Emergency Contraceptive Pills to Spermicide Users in
Ghana**

**Author:** Amy Lovvorn, Joana Nerquaye-Tetteh, Evam Kofi Glover, Alex
Amankwah-Poku, Melissa Hays, and Elizabeth Raymond

**Affiliate:** Family Health International

> Research Triangle Park, North Carolina, USA;
>
> Planned Parenthood Association of Ghana, Accra, Ghana

**Sponsor:** Family Health International (FHI) with funds from the
United States Agency for International Development (USAID).

**Study Location: *Africa,*** Planned Parenthood Association of Ghana

> July 1998 - June 1999

**Publication:** ***Contraception*** 61: 287--293, 2000

**Design:** Nonrandomized clinical trial

> 8 weeks follow-up
>
> Single course of advance EC provision, with opportunity to return for
> additional courses

**METHODS**

**Subject**

A total of 210 women ***spermicide users*** were recruited and enrolled
from 4 Planned Parenthood clinics (Accra, Nkawkaw, Kumasi, Takoradi) in
Ghana, with the following eligibility criteria:

-   Age 18-45 years

-   No current pregnancy.

-   Spermicides as the primary contraception method and EC as a backup
    method during the 8-week study period

-   Expected to have at least 6 coital acts per month

-   No history of thromboembolic disease

Subjects were counseled on the use of spermicide and given at least 40
spermicide tablets, and then non-randomly assigned into the following 2
groups (2 clinic sites each group):

***Control (On Demand Provision) Group:*** 100 subjects recruited from
clinics in Kumasi and Takoradi received EC education and advised to
return to the clinic within 3 days after unprotected intercourse to
obtain EC.

***Advance Provision Group:*** 110 subjects recruited from clinics in
Accra and Nkawkaw were given one packet of EC and advised to return to
the clinic for re-supply immediately if she used, lost, or gave away the
ECPs. Subjects were also asked to refill the ECPs at each of 2 visits.

The EC pills were LoFemenal oral contraceptive pills (each pill contains
0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel).

**Data Collection**

Subjects returned to the clinics for follow-up visits at 4 and 8 weeks
after enrollment to collect the following information: the reason for EC
use or EC request, the dates and times of unprotected sex, the
disposition of ECPs dispensed, side effects of ECPs, coital activity,
and contraceptive use.

**Data Analysis**

All data were presented separately by clinics without any statistical
analysis.

**RESULTS**

**Subject Demographics and Follow-up Compliance**

Of 210 enrolled subjects, 95% (200) provided any follow-up information
for analyses. The duration of follow-up was 8.2-8.6 weeks per subject.

The demographics of the enrolled subjects were summarized in Table 1.
Differences in the following characteristics of subjects were found
among the 4 clinics: age, education, marriage and condom use (unknown
statistical significance).

***Table 1.* Demographics of enrolled subjects**

No. (% of enrolled subjects)

+-------------------------+----------+----------+----------+----------+
| **Characteristics**     | *        |          | *        |          |
|                         | *Advance |          | *Control |          |
|                         | c        |          | c        |          |
|                         | linics** |          | linics** |          |
+-------------------------+----------+----------+----------+----------+
|                         | *        | **N      | **       | **Ta     |
|                         | *Accra** | kawkaw** | Kumasi** | koradi** |
+-------------------------+----------+----------+----------+----------+
| ***Enrolled subjects*** | > **60** | > **50** | > **51** | > **49** |
+-------------------------+----------+----------+----------+----------+
| ***Age (years)***       |          |          |          |          |
+-------------------------+----------+----------+----------+----------+
| > 18--24                | > 20     | > 6 (12) | > 13     | > 14     |
|                         | > (33)   |          | > (25)   | > (29)   |
+-------------------------+----------+----------+----------+----------+
| > 25--34                | > 26     | > 21     | > 14     | > 18     |
|                         | > (43)   | > (42)   | > (27)   | > (37)   |
+-------------------------+----------+----------+----------+----------+
| > ≥ 35                  | > 14     | > 23     | > 24     | > 16     |
|                         | > (23)   | > (46)   | > (47)   | > (33)   |
+-------------------------+----------+----------+----------+----------+
| ***Education***         |          |          |          |          |
+-------------------------+----------+----------+----------+----------+
| > None                  | > 3 (5)  | > 6 (12) | > 11     | > 3 (6)  |
|                         |          |          | > (22)   |          |
+-------------------------+----------+----------+----------+----------+
| > Primary               | > 14     | > 9 (18) | > 21     | > 1 (2)  |
|                         | > (23)   |          | > (41)   |          |
+-------------------------+----------+----------+----------+----------+
| > Middle school         | > 26     | > 22     | > 11     | > 24     |
|                         | > (43)   | > (44)   | > (22)   | > (49)   |
+-------------------------+----------+----------+----------+----------+
| > Higher                | > 17     | > 13     | > 8 (16) | > 21     |
|                         | > (28)   | > (26)   |          | > (43)   |
+-------------------------+----------+----------+----------+----------+
| ***Marital status***    |          |          |          |          |
+-------------------------+----------+----------+----------+----------+
| > Single                | > 8 (13) | > 5 (10) | > 6 (12) | > 21     |
|                         |          |          |          | > (43)   |
+-------------------------+----------+----------+----------+----------+
| > Married               | > 52     | > 45     | > 45     | > 28     |
|                         | > (87)   | > (90)   | > (88)   | > (57)   |
+-------------------------+----------+----------+----------+----------+
| ***Contraception in     |          |          |          |          |
| Past month***           |          |          |          |          |
+-------------------------+----------+----------+----------+----------+
| > Spermicide            | > 51     | > 37     | > 47     | > 21     |
|                         | > (85)   | > (74)   | > (92)   | > (43)   |
+-------------------------+----------+----------+----------+----------+
| > Oral contraceptive    | > 4 (7)  | > 10     | > 0      | > 1 (2)  |
| > pills                 |          | > (20)   |          |          |
+-------------------------+----------+----------+----------+----------+
| > Condom                | > 14     | > 2 (4)  | > 2 (4)  | > 11     |
|                         | > (23)   |          |          | > (22)   |
+-------------------------+----------+----------+----------+----------+
| ***Pregnancy History*** |          |          |          |          |
+-------------------------+----------+----------+----------+----------+
| > Pregnancies (mean)    | > 3.6    | > 3.9    | > 4.5    | > 3.2    |
+-------------------------+----------+----------+----------+----------+
| > Living children       | > 2.3    | > 3.2    | > 2.9    | > 2.0    |
| > (mean)                |          |          |          |          |
+-------------------------+----------+----------+----------+----------+
| >                       | > 1.3    | > 0.7    | > 1.4    | > 1.1    |
|  Miscarriages/abortions |          |          |          |          |
| > (mean)                |          |          |          |          |
+-------------------------+----------+----------+----------+----------+

> Data were extracted from the author's Table 2.

**Changes in Contraceptive Behavior**

Sexual and contraceptive behaviors of subjects before (one month) and
after (approximately 8 weeks) enrollment were summarized in Table 2.

***Table 2.* Sexual and contraceptive behavior**

+-----------------------------+----------+---------+--------+---------+
| **Behavioral Variables**    | *        |         | **C    |         |
|                             | *Advance |         | ontrol |         |
|                             | C        |         | Cli    |         |
|                             | linics** |         | nics** |         |
+-----------------------------+----------+---------+--------+---------+
|                             | *        | **Nk    | **Ku   | **Tak   |
|                             | *Accra** | awkaw** | masi** | oradi** |
+-----------------------------+----------+---------+--------+---------+
| > ***Analyzed subjects***   | > **53** | >       | >      | >       |
|                             |          |  **50** | **48** |  **49** |
+-----------------------------+----------+---------+--------+---------+
| > ***Mean Number of sex     |          |         |        |         |
| > acts†***                  |          |         |        |         |
+-----------------------------+----------+---------+--------+---------+
| > Month before enrollment   | > 7.1    | > 11.4  | > 9.4  | > 10.9  |
+-----------------------------+----------+---------+--------+---------+
| > During study              | > 18.1   | > 24.3  | > 18.4 | > 24.6  |
+-----------------------------+----------+---------+--------+---------+
| > ***Mean Unprotected sex   |          |         |        |         |
| > acts‡***                  |          |         |        |         |
+-----------------------------+----------+---------+--------+---------+
| > Month before enrollment   | > 1.3    | > 0.1   | > 1.2  | > 2.9   |
+-----------------------------+----------+---------+--------+---------+
| > During study              | > 1.2    | > 0.1   | > 0.2  | > 0.1   |
+-----------------------------+----------+---------+--------+---------+
| > ***EC Use during study (8 |          |         |        |         |
| > weeks)***                 |          |         |        |         |
+-----------------------------+----------+---------+--------+---------+
| > Total subjects            | > 48     | > 6     | > 14   | > 6     |
|                             | > (91)   | > (12)  | > (29) | > (12)  |
+-----------------------------+----------+---------+--------+---------+
| > 0 use                     | > 5 (9)  | > 44    | > 34   | > 43    |
|                             |          | > (88)  | > (71) | > (88)  |
+-----------------------------+----------+---------+--------+---------+
| > 1 use                     | > 26     | > 5     | > 10   | > 6     |
|                             | > (49)   | > (10)  | > (21) | > (12)  |
+-----------------------------+----------+---------+--------+---------+
| > 2 uses                    | > 16     | > 0     | > 3    | > 0     |
|                             | > (30)   |         | > (6)  |         |
+-----------------------------+----------+---------+--------+---------+
| > 3 uses                    | > 6 (11) | > 1 (2) | > 1    | > 0     |
|                             |          |         | > (2)  |         |
+-----------------------------+----------+---------+--------+---------+

Data were extracted from the author's Table 3 but
re-processed/re-calculated.

† mean sex acts per subjects; ‡ % of unprotected sex over total sex
acts.

\* % of EC use over unprotected sex.

***Unprotected sex:*** The mean number of sex acts per participant per
month increased at all clinic sites, but the proportion of acts that
were unprotected declined.. This study was not randomized and there were
imbalances between study sites in many factors. Comparisons between
Advanced Clinics and Controlled Clinics are not valid.

***EC use:*** Subjects in Advance Clinics group seemed more likely to
use EC although this conclusion is powered by the Accura site. Repeat
use was 8% in 3 clinical sites (41% in Accra site).

***Condom use:*** Changes on condom use was not assessed during the
study.

***Primary contraception:*** Change in primary contraception
(spermicide) before and after enrollment, and the differences in primary
contraception between Advance and Control were not reported.

**COMMENTS**

1.  Study has significant flaws; the assignment was not randomized and
    there was great variability in demographics between the 4 clinic
    sites.

2.  Study subjects did not have access to other forms of contraception.

3.  The study was conducted outside US, and is not readily generalizable
    to US population, particularly an OTC setting.

4.  A single course of EC was provided to the advance provision group.
    Subjects were asked to receive refills of advanced EC. There was 41%
    of participants that had repeat use at one advanced provision clinic
    and 2% at the other. This compared to 8% at one "on demand" clinic
    and 0 % at the other "on demand" clinic.

5.  There were 2 follow-up visits (weeks 4 and 8) during the study.
    However, comparisons in sexual and contraceptive behaviors of
    subjects between 2 visits were not reported.

**CONCLUSION**

1.  Subjects with advance EC access were more likely to use EC.

2.  Behavioral changes between groups can not be assessed due to
    significant deficiency in study design.

> ***Literature* #8** (vol 13, page 011a)

**Emergency Contraception: Randomized Comparison of Advance Provision
and Information Only**

**Author:** Charlotte Ellertson, Shubba Ambardekar, Allison Hedley,
Kurus Coyaji, James Trussell, and Kelly Blanchard

**Affiliate:** Population Council, Mexico City, Mexico (CE)

K.E.M. Hospital, Pune, India (SA, KC)

Office of Population Research, Princeton University (AH, JT),

Population Council, Johannesburg, South Africa (KB)

**Sponsor:** The David and Lucile Packard Foundation (Los Altos,
California) funded this study

**Study Location:** ***India,*** family planning clinics

From April 1997 to June 2000

**Publication:** ***Obstet Gynecol*** 98:570-575, 2001

**Design:** Randomized clinical trial

> 1-year follow-up (38% 12-month and 90% 3-month)
>
> Three courses of advance EC provision

**METHODS**

**Subject**

A total of 411 ***condom users*** visiting an urban family planning
clinic in Pune (India) between April 1997 and June 2000 were recruited
and randomly assigned into the following 2 groups:

***Control group:*** 198 women received EC education to obtain emergency
contraception if needed.

***Advance EC group:*** 213 women received EC education plus ***three
courses*** of EC pills (Yuzpe regimen). Each course consisted of 8
tablets (30 mg ethinyl estradiol and 30 mg norgestrel per tablet) of
combined oral contraceptive.

**Data Collection**

Subjects returned quarterly to the clinic for follow-up for up to 1 year
to collect information about frequency of unprotected intercourse, EC
use, pregnancies, and sexually transmitted infections.

**RESULTS**

**Subject Demographics (Table 1)**

The mean age was 25 years, and approximately 5% of subjects were \< 20
years old. Comparability of the educational levels in India to the US
was unknown; apparently, 84% of subjects completed ≥ 9 years education.

***Table 1.* Demographics and Follow-up Compliance of Enrolled
Subjects**

+---------------------------------+-----------------+-----------------+
| > **Characteristics**           | **Control**     | **Advance EC**  |
|                                 |                 |                 |
|                                 | **(*n* = 198)** | **(*n* = 213)** |
+---------------------------------+-----------------+-----------------+
| > ***Age (years),*** *No. (%)*  |                 |                 |
+---------------------------------+-----------------+-----------------+
| > \< 20                         | > 10 (5)        | > 9 (4)         |
+---------------------------------+-----------------+-----------------+
| > 20--29                        | > 166 (84)      | > 172 (81)      |
+---------------------------------+-----------------+-----------------+
| > \> 30                         | > 22 (11)       | > 32 (15)       |
+---------------------------------+-----------------+-----------------+
| > Mean ±SD                      | > 24.9 (3.7)    | > 25.1 (3.8)    |
+---------------------------------+-----------------+-----------------+
| > ***Years of schooling,***     |                 |                 |
| > *No. (%)*                     |                 |                 |
+---------------------------------+-----------------+-----------------+
| > 0--8                          | > 29 (15)       | > 36 (17)       |
+---------------------------------+-----------------+-----------------+
| > 9--12                         | > 96 (48)       | > 103 (48)      |
+---------------------------------+-----------------+-----------------+
| > 13--16                        | > 60 (30)       | > 61 (29)       |
+---------------------------------+-----------------+-----------------+
| > \> 16                         | > 13 (7)        | > 13 (6)        |
+---------------------------------+-----------------+-----------------+
| > Mean ± SD                     | > 11.7 ± 3.5    | > 11.4 ± 3.4    |
+---------------------------------+-----------------+-----------------+
| > ***Follow-up Compliance†,**   |                 |                 |
| > No. (%)*                      |                 |                 |
+---------------------------------+-----------------+-----------------+
| > Lost to Follow-up             | > 45 (33)       | > 34 (16)       |
+---------------------------------+-----------------+-----------------+
| > 3 months                      | > 172 (87)      | > 194 (91)      |
+---------------------------------+-----------------+-----------------+
| > 12 months                     | > 66 (33)       | > 99 (46)       |
+---------------------------------+-----------------+-----------------+

> Data were adapted form the author's Table 1, otherwise from Table 2
> and Figure 1 (†).

**Follow-up Compliance**

Approximately 87% (172 in control group) and 91% (194 in advance EC
group) of subjects completed at least 3 months in study and available
for analysis. Women who switched to non-barrier contraceptives left the
study.

**Sexual and Contraceptive Behavior (Table 2)**

***Unprotected sex:*** Women with advance EC provision did not have
statistically greater frequency of unprotected sex and a similar
proportion of women on the two study arms reported unprotected sex
during the study, 8% in the advanced provision vs. 6% in the control
group.

***EC use:*** Women with advance EC provision were more likely to use EC
pills (79% vs 44%) after unprotected intercourse(Eleven (5%) EC users
were in the Advanced Provision group and four (2%) in the control
group)..

***Condom use:*** The study subjects used condom as a primary
contraception method and 23% in both arms went off study because they
changed to a more effective contraceptive method. Ninety-eight percent
of women in the advanced supply arm stated that availability of EC did
not "tempt them to talk changes with their condoms".

***STDs:*** one subject reported an STD. Details of the STD (nature and
study group) were not provided in the report. STDs were self reported
and no clinical laboratory screening was performed.

***Table 2.* Unprotected sex and Emergency contraceptive Use**

(Excluded 24 subjects who left the study)

+---------------------------------+----------+-------------+----------+
| **Unprotected Intercourse**     | **C      | **Advance   | ***P*    |
|                                 | ontrol** | EC**        | value**  |
+---------------------------------+----------+-------------+----------+
| > Mean number of unprotected    | > 0.016  | > 0.012     | > 0.62   |
| > sex acts per                  |          |             |          |
| >                               |          |             |          |
| > month among all women         |          |             |          |
| > followed                      |          |             |          |
+---------------------------------+----------+-------------+----------+
| > Median number of unprotected  | > 0.250  | > 0.292     | > 0.97   |
| > sex acts per                  |          |             |          |
| >                               |          |             |          |
| > month among women with at     |          |             |          |
| > least                         |          |             |          |
| >                               |          |             |          |
| > one unprotected sex           |          |             |          |
+---------------------------------+----------+-------------+----------+
| > Number of women, *no.* (%)    | > 9/157  | > 14/185    | > 0.53   |
|                                 | > *      | > **(7.6)** |          |
|                                 | *(5.7)** |             |          |
+---------------------------------+----------+-------------+----------+
| > EC use, *no.* (%)             | > 4/9    | > 11/14     | > 0.18   |
|                                 | > (44.4) | > (78.6)    |          |
+---------------------------------+----------+-------------+----------+

Data were adapted from the author's Table 3.

**COMMENTS**

1.  It is not clear if the rate of unprotected sex changed from baseline
    since baseline information (at the enrollment) was not provided.

2.  The study was conducted in India, which is unlikely to be
    representative of US population.

**CONCLUSION**

Advance EC provision did not appear to increase the frequency of
unprotected sex as compared to control in the population who used condom
as a primary contraception method. The proportion of participants who
did have unprotected sex who used EC was higher in the Advanced EC
group.