# **Contraceptive Update: Pills, Shots, Patches and Rings**

## 

## **John Kulig, MD, MPH**

# **Laurie Hornberger MD, MPH**

## **Job Corps Regional Medical Consultants**

# 

# 

# **Sexual risk behavior**

## ever had sexual intercourse male female

## grade 9 41% 29%

## grade 10 42% 39%

## grade 11 54% 50%

## grade 12 61% 60%

## 

## [\>]{.underline}4 lifetime sexual partners male female

## grade 9 14% 6%

## grade 12 24% 20%

## Source: CDC 2001 Youth Risk Behavior Survey

# 

# 

# **Sexual risk behavior**

## initiation of sexual intercourse before age 13

## male students 9%

## female students 4%

## white students 5% 

## black students 16%

## Hispanic students 8%

## all students 7%

## Source: CDC 2001 Youth Risk Behavior Survey

# 

# 

# **Sexual risk behavior**

## condom use during last sexual intercourse

## white students 57% 

## black students 67%

## Hispanic students 54%

## alcohol or drug use at last sexual intercourse

## male students 31%

## female students 21%

## white students 28%

## black students 18%

## Hispanic students 24%

## Source: CDC 2001 Youth Risk Behavior Survey

# 

# 

# 

# **Adolescent Pregnancy**

## *"Have been pregnant or gotten someone pregnant."*

## male 4%

## female 5%

## white 3%

## black 11%

## Hispanic 6%

## Source: CDC 2001 Youth Risk Behavior Survey

# 

# **OCs: New progestins**

## 1st generation:

## norethindrone

## 2nd generation:

## norgestrel

## levonorgestrel

## 3rd generation:

## desogestrel

## norgestimate

## new:

## drospirenone

# 

# **Noncontraceptive Benefits of OCs**

## decrease menstrual flow (lighter, shorter periods)

## decrease menstrual cramps (no ovulation)

## improve anemia (lighter, shorter periods)

## improve acne (estrogen effect)

## protect against ovarian and endometrial cancer

## decrease benign breast disease 

## decrease ovarian cyst formation

## prevent ectopic pregnancy

## protect against some causes of PID

## protect against osteoporosis

# 

# **Oral Contraceptives and Risk of Breast Cancer**

## study of 4575 women with breast cancer and 4682 controls - age 35 to 64 years at interview

## relative risk 1.0 \[0.8-1.3\] for current OC users

## relative risk 0.9 \[0.8-1.0\] for previous OC users

## similar results in white and black women

## relative risk did not increase with longer use or with higher estrogen dose

## no increased risk associated with initiation of OC use in adolescence

## NEJM 2002;346:2025-2032

# 

# 

# **Drug Interactions with OCs**

##  most anticonvulsants (except valproate)

##  rifampin

##  griseofulvin

##  St. John's Wort

# 

# **Seasonale^®^**

-   extended regimen combined oral contraceptive pills with ethinyl
    estradiol and levonorgestrel

-   91 day cycles - 84 days on - 7 days off

-   4 menstrual cycles per year - one each season

-   clinical trials underway

####### FDA approval anticipated in 2004 

# 

# **What is the best method of emergency contraception (EC) for use by adolescents?**

## Options:

## Yuzpe method (1982)

## combination oral contraceptive pills

## progestin- only pills

## dedicated emergency contraceptive pill products: Preven^®^ and Plan B^®^

## mifepristone (RU486)

## insertion of intrauterine device

# 

# **How does EC work?**

## mechanism of action of levonorgestrel [+]{.underline} ethinyl estradiol may depend upon timing during the menstrual cycle

## principal mechanism is prevention of ovulation

## may thicken cervical mucus 

## may interfere with transport of sperm, ova or zygote

## may inhibit implantation

## onset of pregnancy is medically defined as implantation of a fertilized ovum in the wall of the uterus (ACOG)

## levonorgestrel [+]{.underline} ethinyl estradiol is [not]{.underline} effective once implantation occurs

## levonorgestrel [+]{.underline} ethinyl estradiol does [not]{.underline} induce abortion

# **How effective is EC?**

## Pregnancy risk:

## 33% per cycle if sexually active qod

## 15% per cycle if sexually active once a week

## condom failure reported by 4%-7% of couples during a three-month interval

## EC use could prevent 2 million unintended births and 1 million induced abortions each year in the US

# 

# 

# 

# **How effective is EC?**

## Yutzpe regimen data:

## EC efficacy 74% by meta analysis of ten studies

## 0.5%-1.5% observed vs 4.7%-5.5% expected pregnancy rate

## no absolute contraindications except pregnancy

## no demonstrable teratogenicity

# 

# **How effective is EC?**

## Importance of timing: combined pill data

## 77% effective if taken within 24 hours of unprotected intercourse

## efficacy declines to 36% if treatment is delayed 25-48 hours

## efficacy declines to 31% if treatment is delayed beyond 48 hours

# 

# **How effective is EC?**

## Importance of timing: Plan B**^®^** data

## 95% effective if taken within 24 hours of unprotected intercourse -- reduces crude pregnancy rate from 8% to 0.4%

## efficacy declines to 85% if treatment is delayed 25-48 hours

## efficacy declines to 58%-61% if treatment is delayed beyond 48 hours

# 

# **Are there medical contraindications to EC use?**

## only absolute contraindication is pregnancy (because EC will not work)

## no evidence of harm to a developing fetus

## no concern about estrogen-related contraindications with progestin-only EC

## potential drug interactions with certain anticonvulsants, rifampin and griseofulvin may reduce efficacy

# 

# **Is pregnancy testing necessary before using EC?**

## EC is ineffective if implantation has occurred

## no evidence of harm to developing fetus if EC is taken inadvertently

## routine pregnancy testing is not recommended

## consider pregnancy testing [prior]{.underline} to EC use if menses delayed 

## consider pregnancy testing [after]{.underline} EC use if menses does not occur within 3 weeks 

# 

# **Should an anti-emetic be prescribed with EC?**

## Nausea:

## Yuzpe regimen 50.5%

## Plan B**^®^** 23.1%

## Vomiting:

## Yuzpe regimen 18.8%

## Plan B**^®^** 5.6%

## Data from a multi-center randomized clinical trial of 1,998 women.

# 

# 

# **Should EC be prescribed in advance of need?**

## women receiving EC in advance are two to three times more likely to use them, but not to use them repeatedly (US/Scotland)

## 80% of women who received EC in advance began treatment within 24 hours of intercourse vs 40% of women who needed to fill an EC prescription

## no more likely to engage in sexual activity

## no more likely to use their regular contraceptive less consistently

## fewer than one third of female adolescents have heard of EC (1998 data)

## 17% of young women report no use of contraception at most recent intercourse

## 20% of women report forced sexual intercourse and 72% were under age 20 at the time of the experience (NCHS)

## lack of clinician availability on weekends may disproportionately affect adolescents

# 

# **Should EC be made available without a clinician's prescription?**

## Citizen's Petition filed with the FDA in February 2001 -- 70 organizations

## currently available over-the-counter in 13 industrialized nations

## currently available from pharmacists in the states of California and Washington

## Ref: NEJM 2002;347:846-849

# 

# **Should EC be made available without a clinician's prescription?**

## Arguments [in favor]{.underline} of OTC availability:

## improved public health

## delays in treatment lead to more unintended pregnancies

## easier access to EC 24 hours a day

## safe for self-medication

## same dose for all women

## same medications safely used for contraception for decades

## serious adverse effects do not occur, even with inappropriate use

## Arguments [opposed]{.underline} to OTC availability:

## no clinician contact to discuss potential side effects

## missed opportunity for contraceptive counseling

## may make refusal of sexual intercourse more difficult

## EC is a euphemism for induced early abortion

## EC might unintentionally be used in pregnancy

## EC use might undermine use of non-emergency contraception, including barrier methods

# **Does knowledge of EC alter adolescent sexual behavior?**

## study of 916 male and 852 female students age 14-15 in 12 schools in UK

## single lesson on emergency contraception

## improved knowledge persisted six months later in comparison with controls

## no difference in sexual activity, intent to use EC or use of EC 

## Ref: BMJ 2002:324:1179-1183

# 

# **Emergency Contraception Resources**

## EC hotline 1.888.NOT.2.LATE

## EC website [http://not-2-late.com](http://not-2-late.com/)

## Clinician's guide to providing EC - <http://www.piwh.org/publications.html>

## Consortium for Emergency Contraception - <http://www.cecinfo.org/>

## 

# **Depo Provera^^ \[www.depoprovera.com\]**

##  depot medroxyprogesterone acetate150 mg IM once every 12 weeks

##  irregular bleeding =\> amenorrhea within 2 years (70%)

##  concerns: weight gain

## osteoporosis risk

# 

# **Combined injectable contraceptives**

## **Lunelle^^ \[www.lunelle.com\]**

### 25 mg depot-medroxyprogesterone acetate and 5 mg estradiol cypionate injected (IM) once a month

### 0.5 mL IM q 30 days [+]{.underline} 3 days

### FDA approved in October 2000

### prefilled syringes withdrawn from the market in October 2002 - potency concerns

# 

# **Lunelle^^ : Contraceptive Benefits**

## highly effective (0.1-0.4 pregnancies per 100 women during the first year of use)

## effective immediately

## does not interfere with intercourse

## few side effects

## can be provided by trained nonmedical staff

## no supplies needed by the patient

# 

# **Lunelle^^: When to Start**

## anytime you can be reasonably sure the patient is not pregnant

## days 1 to 7 of the menstrual cycle

## postpartum:

### after 6 months if breastfeeding

### after 3 - 6 weeks if not breastfeeding

## postabortion (immediately or within 7 days)

# 

# **Ortho Evra^^ \[www.orthoevra.com\]**

## seven day contraceptive patch

## 1 ^3/4^ inch three layer adhesive patch

## contains both estrogen and progestin

## applied to the buttocks, lower abdomen or upper body

## newly applied weekly for three weeks, then one week off for menses

## less effective in women over 198 pounds

## approved by the FDA in November 2001

# **Ortho Evra^^**

## Side effects leading to discontinuation:

## nausea (2%)

## moodiness (1.5%)

## headache (1.1%)

## breast discomfort (1%)

## irritation at application site (1.9%)

## Inadvertent detachment uncommon (1.9%), even with exercise, humid climates, saunas, hot tubs

# 

# **NuvaRing^^ \[www.nuvaring.com\]**

## contraceptive vaginal ring - 2 inch diameter

## worn for 21 days =\> removed for 7 days to allow menses =\> replaced with new ring

## releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily

## one size only - does not require fitting 

## cannot be inserted incorrectly

## no increase in vaginal infections/discharge

## 3 hour window after inadvertent removal

# 

# **Implanon^^**

## progestin-only contraceptive implant 

## single flexible 4 cm rod inserted under the skin of the upper arm 

## contains 68 mg etonogestrel - releases 

## 40 mcg daily - 3 year efficacy 

## no pregnancies in 73,000 monthly cycles

## irregular menstrual bleeding common 

## clinician visit for insertion and removal

# 

# **Mirena^^ \[www.mirena-us.com\]**

## levonorgestrel-releasing intrauterine system - 20 mcg daily - 5 year efficacy

## highest risk of PID within 20 days of insertion

## irregular menstrual bleeding common in first 3-6 months

## clinician visit for insertion and removal

# 

# **Condom Use and Hormonal Contraception**

## Consistent condom use

## OCs 21%

## DMPA 18% 

## Norplant 9%

## Condom use at last intercourse

## hormonal contraception 52%

## no hormonal contraception 69%

## **Keeping current on reproductive health issues**

## **The Contraception Report**

## A quarterly update on what's new in contraception. Profiles new products and updates information on existing ones. The report is now available online at [www.contraceptiononline.org/contrareport/issue.cfm]{.underline} or you can get a FREE subscription at [www.emron.com/TCR](http://www.emron.com/TCR)

## 

## 

## **Sexually Transmitted Disease Guidelines 2002**

## 

## *In May 2002, the Centers for Disease Control and Prevention (CDC) presented their latest edition of guidelines for the evaluation and management of sexually transmitted diseases. The highlights are:*

## 

## **Chlamydia**

## *All* sexually active teens and young adults should be screened annually, regardless of presence or absence of symptoms.

## *All* women with chlamydial infections should be rescreened 3-4 months after treatment is completed.

## 

## **Gonorrhea**

## Resistance to fluorquinolone antibiotics (ciprofloxacin, ofloxacin, levofloxacin) has been found on the West Coast. It is unknown how extensive this resistance will become or how quickly it may spread.

## Cefixime and ceftriaxone are now considered the first line drugs to treat GC on the West Coast, but cefixime is no longer manufactured in the US.

## 

## **Expanded risk assessment for gay and bisexual men**

## Annual STD screening for chlamydia (anal, urethral), gonorrhea (anal, urethral, pharyngeal), HIV and syphilis.

## Routine vaccination for hepatitis A and B.

## 

## **Use of Nonoxynol-9**

## Frequent use of the spermicide nonoxynol-9 has been shown to cause genital (vaginal, rectal) lesions that can increase the risk of HIV transmission.

## Condoms lubricated with nonoxynol-9 are no longer recommended. (Previously purchased condoms with N-9 can however be used up until their expiration date.)

## 

## To get a copy of the 2002 CDC STD Guidelines, call 1-888-232-3228 or visit [www.cdc.gov/std](http://www.cdc.gov/std) =\> [www.cdc.gov/std/treatment/default.htm](http://www.cdc.gov/std/treatment/default.htm)

##