Clinical trial NCT02175030
Conditions: Contraception
Keywords: Emergency contraception Levonorgestrel IUD Copper IUD
Sponsor: University of Utah
Start date: 2016-08-01; Completion date: 2020-12-01
Enrollment: 711 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the most effective method of emergency contraception vs. the levonorgestrel IUD, the most preferred IUD which has never been tested as an emergency contraceptive. This research has the potential to increase use of highly effective contraception in a high-risk population and lower the persistently elevated rate of U.S. unintended pregnancy.

Detailed description:
Unintended pregnancy has multiple adverse effects on both maternal and child health. The United States continues to have one of the highest rates of unintended pregnancy among developed countries. To combat this problem, we are studying initiation of the highly effective intrauterine device (IUD) for women presenting for emergency contraception (EC). This is an ideal population to initiate highly effective reversible contraception (HERC) as they are at high risk of unintended pregnancy and are acting to reduce that risk. We have recently demonstrated significantly lower pregnancy rates 12 months after presenting for EC among women who selected the copper IUD versus those who selected oral Levonorgestrel (LNG).

Not only is the copper IUD the most effective method of EC, it is considered a top tier anticipatory contraception method and its ability to prevent pregnancy is on par with tubal sterilization (less than 1% in the first year with lower failure rates in subsequent years). However, women selecting intrauterine contraception have shown a strong preference for the LNG IUD. The LNG IUD, is as effective at preventing pregnancy as the Copper IUD, and has some non-contraceptive effects that many women see as benefits such as the reduction or elimination of menstrual bleeding and menstrual related discomfort. Of currently available reversible contraceptives, the LNG IUD has the highest levels of user satisfaction and continuation. However, its effectiveness as an emergency contraceptive remains unknown. A randomized control trial is necessary to assess the safety and efficacy of the LNG IUD as EC. Demonstrating the efficacy, safety, and acceptability of the LNG IUD for EC will improve options for women seeking EC and who desire a highly effective method of contraception.

Arms: arm 1: Randomized to copper T380 IUD for EC (emergency contraception) arm 2: Randomized to LNG20 IUD for EC (emergency contraception)
Interventions: intervention 1: Copper IUD intervention 2: Levonorgestrel IUD
Intervention descriptions: intervention 1: Randomization to copper/Paragard IUD for emergency contraception intervention 2: Randomization to Levonorgestrel/Mirena IUD for emergency contraception

Protocol documents:
Prot_SAP_000.pdf: 
 
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RAPID EC – RCT Assessing Pregnancy with Intrauterine 
Devices for Emergency Contraception 
 
 
Protocol Summary 
 
 
 
IRB Approval 
Date of 
Current 
Version: 
1/10/2022 
University of 
Utah IRB #: 
IRB_00073554 
Sponsor: NIH NATIONAL INST CHILD HLTH & HUMAN DEV 
  
Principal 
Investigator: 
David Turok 
Internal Staff 
and  Sub-
Investigators: 
Site Name 
Staff Names 
University of Utah 
David Turok 
 
Jasmin Alcantara 
 
Lori Gawron 
 
Gentry Carter 
 
Alexandra Gero 
 
Rebecca Simmons 
 
Cristen Dalessandro 
 
Jessica Sanders 
 
Corinne Sexsmith 
 
Douglas Routh 
 
Amy Orr 
 
Amy Alcantara 
 
Marina Kern 
 
Jennifer Kaiser 
Planned Parenthood Assoc of Utah David Turok 
 
 
 
This document was created using the ERICA Online System at the University of Utah. The document is created 
from study information approved by the IRB on the date listed above.  Any alteration to the original content of this 
document may not be considered to represent the study as approved by the IRB.  
 
 


 
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Background and Introduction 
 
In order to reduce our nation’s persistently elevated rate of unplanned pregnancy we must seek 
every opportunity to provide women who desire contraception with the most effective 
methods. The vast majority of the 3.1 million unintended pregnancies in the U.S. each year 
result from situations where contraception was used imperfectly or not at all.1 Unfortunately, 
the wide availability of oral EC pills has not reduced abortion rates.2, 3 Providing non-users 
and users of less effective methods of contraception with highly effective contraception is an 
efficient strategy to reduce rates of unplanned pregnancy and abortion. Application of this 
principal has reduced repeat abortions for women who receive immediate post-abortal IUD 
insertion.4  Like women seeking abortion, EC users are at high risk of unplanned pregnancy 
and are making a conscious effort to acutely reduce that risk. 
The demand for EC confirms a tremendous unmet public health need for more reliable and 
more effective contraception. The copper IUD is the most efficacious method of EC 
(pregnancy rates of 0.1%)[1] and offers continued highly effective contraception for over a 
decade.  While its use is supported by a Cochrane Review,7 ACOG,8 and several other 
professional organizations and authors,9-15 it is rarely used.  While the copper IUD for EC has 
advantages over oral EC pills, U.S. women selecting IUDs outside of the EC setting have 
shown a strong preference for the LNG IUD as it minimizes or eliminates menstrual bleeding 
and discomfort.[2, 3]. The Contraceptive CHOICE project 18 illustrates this.  Of the 9,256 
women enrolled in this prospective cohort who were provided with their contraceptive method 
of choice without cost  47% of participants selected the LNG IUD and 9% the copper 
IUD.  We are unaware if offering women the option to receive either IUD method will 
increase uptake of highly effective methods by EC users. 
Offering women presenting for EC the option of the LNG or copper IUD may increase the 
initiation of highly effective methods of contraception among a population at high risk of 
unintended pregnancy. Leaders in the field of EC, acknowledging the lack of effect of 
increasing availability to EC pills on reducing rates of unplanned pregnancy, have called for 
procedures that streamline the delivery of highly effective methods of contraception when 
women present for EC.16 
Our research team working in conjunction with our clinical partners at Planned Parenthood 
Association of Utah (PPAU) have conducted several studies evaluating use of the IUD in 
women presenting for EC. The cumulative findings of our research to date show that EC users 
are willing to have the copper IUD placed[4, 5] and those that obtain it have lower pregnancy 
rates than those choosing oral LNG for EC.[6]  Our recent study assessing the LNG IUD with 
oral LNG for EC users has shown no pregnancies with 110 women using this approach.  In 
addition, 90% of participants agreed to being randomized to either type of IUD. The potential 
to further reduce unintended pregnancy in a high risk population by offering the preferred 
method of IUD supports a randomized controlled trial of the copper and LNG IUDs for EC 
users. 
Study Design: 


 
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Non-inferiority randomized controlled trial.  If recruitment is not adequate with this design and 
potential participants report concern about randomization as a reason for non-participation 
then a patient-preference cohort (PPC) will be offered to interested and qualified individuals. 
All women presenting to participating clinics when study participation is offered will be 
presented with a study information sheet (discussed below) which includes an assessment of 
interest in the study.  If we find that we are not able to meet recruitment goals (e.g. <80 
participants enrolled in the first 6 months) and the reason for non-participation is assessed to 
be lack of willingness to be randomized to the study interventions, then we will add an option 
for a PPC.  Should the PPC be introduced then participants who are interested in the study and 
eligible for participation but not willing to be randomized will be offered participation 
through the PPC which has a separate consent form.  While 90% of EC users enrolled in a 
current study where they can choose their IUD type stated they would be be willing to be 
randomized to either type of IUD, some individuals may be reluctant to agree to random 
assignment.  This potentially impacts result generalizability. In order to evaluate the 
magnitude and direction of non-participation bias we will offer eligible women presenting for 
EC who desire an IUD but are not willing to undergo randomization participation in a patient-
preference cohort (PPC).   Participants in the PPC may choose the IUD they desire.  Based on 
our survey of current participants in an EC Trial offering women the copper IUD or the LNG 
IUD and oral LNG we expect that the significant majority of potential participants in this trial 
will agree to randomization. The PPC will allow us to ascertain selection bias due to RCT non-
participation.  We will evaluate participant demographics and clinical characteristics.  This 
strategy has been successfully used the OPUS trial, an RCT assessing a mid-urethral sling or 
sham incisions at the time of pelvic organ prolapse repair.[7] 
 
 
 
Purpose and Objectives 
 
In this prospective observational study, all women presenting for Emergency Contraception 
(EC) at Planned Parenthood Association of Utah (PPAU) clinics will be counseled using a 
standardized script; those interested in an IUD, who meet study qualifications and agree to 
participate, will be randomized to either the hormonal IUD (LNG 52mg IUD commonly 
known as Mirena® or Lilleta®) or the copper IUD (Paragard®). Participants will be followed 
for one year.  If enrollment goals are not achieved due to a lack of willingness among potential 
participants to be randomized then we will initiate a PPC (patient preference cohort).  In that 
case, participants who are interested in the study and eligible for participation but not willing 
to be randomized will be offered participation in a PPC. 
  
This study has three specific objectives. 
  
Objective 1:  Determine the efficacy of the levonorgestrel IUD and copper T380 IUD for 
emergency contraception as assessed by urine pregnancy tests 1 month  after EC use. 
Hypothesis: The LNG IUD is non-inferior to the copper T380 IUD for EC based on a 1% non-
inferiority limit. 


 
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Objective 2:  Compare the one-year unintended pregnancy rates from women initiating the 
levonorgestrel IUD vs. copper T380 IUD for EC. 
Hypothesis: At one-year the LNG IUD users will have lower pregnancy rates compared to 
copper IUD users. 
Objective 3:  Assess the one-year continuation, satisfaction, pain, and bleeding patterns of a 
LNG20 IUD to a copper T380 IUC as a method of EC and the mechanisms of continuation. 
Hypothesis: The LNG IUD will have superior rates of continuation and non-inferior 
satisfaction (what about pain and bleeding patterns) compared to the copper IUD as a method 
of EC and the mechanisms of continuation. 
 
 
 
Study Population 
 
Age of Participants: Women ages 18-35 
 
Sample Size: 
At Utah: 
706  
All Centers: 
Up to 850 
 
Inclusion Criteria: 
Eligible participants must be: 
  
1. Between 18-35 years old 
  
2. In need of EC (had unprotected intercourse within 120 hours – 5 days) 
  
3. Desire to prevent pregnancy for 1 year 
  
4. Fluent in English and/or Spanish 
  
5. Have a regular menstrual cycle (21-35 days) 
  
6. Know their last menstrual period (+/-3 days) 
  
7. Be willing to comply with the study requirements 
  
8. Participants current preferred phone number must be functioning at the time of study 
entry and will be tested prior to enrollment 
 
 
Exclusion Criteria: 
1. Current pregnancy 
  


 
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2. Breastfeeding 
  
3. Intrauterine infection within the past 3 months 
  
4. Sterilization 
  
5. Already have an IUD or contraceptive implant (Nexplanon) in place 
  
6. Vaginal bleeding of unknown etiology 
  
7. Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated 
at least 7 days prior to study entry) 
  
8. Allergy to copper or Wilson's disease 
9. Known abnormalities of the uterus that distort the uterine cavity 
10. Use of oral emergency contraception within 5 days prior to enrollment 
 
 
 
Design  
 
Prospective Biomedical Intervention or Experiment 
Randomized Trial 
 
 
Both medications being studied in this trial are FDA approved and have undergone 
Phase 3 testing and extensive post-market surveillance. This study evaluates both of 
these medications for off label use as emergency contraceptives.  
 
If enrollment goals are not being met (for example, <80 enrolled in the first 6 months 
or less than 10 participants per site at any time in the study when staff are available to 
enroll participants) and lack of willingness to be randomized is a stated barrier to 
participation, then we will introduce a PPC whereby participants who are interested in 
the study and eligible for participation but not willing to be randomized will be offered 
participation in a patient-preference cohort (PPC). 
 
 
Study Procedures 
 
Recruitment/Participant Identification Process: 
Women who present for emergency contraception at Planned Parenthood clinics will be 
provided with an information sheet describing the two IUD options offered in this study.  This 
will be provided to them by a member of the PPAU clinical staff.  The information sheet also 
asks if they are interested in participating in a study where they would be randomized to one of 
the two IUDs offered in this study.  They are also asked for age, ethnicity, site, and reason for 
declining participation.  They are asked to mark Yes or No before giving the information sheet 
back to the clinical staff member.  No identifiable information is collected on these participant 


 
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information sheets and unless a woman agrees to screening for the study, she is not listed in a 
screening log.  
Those women who mark yes are then approached either by the study coordinator or other IRB 
approved research staff for further screening and information on the study.  
Note:  Women who are under age 18 will be included in those who present for emergency 
contraception at Planned Parenthood clinics and complete the study information sheet.   After 
a member of the research team reviews the initial eligibility criteria, these under age 18 
women would be considered screen failures and would not be offered participation in the 
study.  
Should the PPC be initiated, then potential participants interested in the study but who decline 
randomization will be offered participation in the PPC. 
 
 
Informed Consent: 
Description of location(s) where consent will be obtained:  
Consent will be obtained in a private examination room at the clinic where the patient is 
receiving care. 
 
Description of the consent process(es), including the timing of consent:  
Due to the nature of this study, it may not be possible for patients to return at a later time to 
enroll in the study. Participants will have all questions answered prior to enrollment. The 
research staff are experienced in interviewing and working with this population. They will be 
certain to take the time needed to ensure that the patient understands the study and is 
consenting willingly. If the woman continues to have questions, she will be offered the 
opportunity to discuss the study in further detail with the PI or other medical providers with 
extensive experience with the clinical care of IUDs and emergency contraception. 
 
Procedures: 
Women who meet inclusion/exclusion criteria will be offered participation in the 
randomization arm of the study.  For those who agree, they will be randomized to either the 
copper IUD or the LNG IUD and the study procedures below will apply. All participants in the 
RCT will be informed to use a backup method of contraception (e.g. condoms) or sexual 
abstinence for the next 7 days to protect against unplanned pregnancy as women assigned to 
the LNG IUD will need this early protection.  Providing this information to only women in the 
LNG IUD group could inform them of which device they received in the first month.  This is a 
component of the treatment blinding.  In the PPC only women selecting the LNG IDU will be 
informed to use a backup method as the copper IUD protects against future pregnancy risk 
immediately.  
Should enrollment not meet expectations as previously described, then for those patients who 
meet all inclusion/exclusion criteria and wish to participate in the study, but do not agree to 
random assignment, we will offer them participation in a PPC.  Participants in the PPC may 


 
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choose the IUD they desire.  Once the participant decides which IUD they prefer, the study 
procedures below will apply.  
Enrollment (Initial Clinic Visit)  
 Consent process 
 Urine pregnancy test (Completed at the Planned Parenthood Clinic Lab) 
 Assignment to either randomized arm or PPC arm 
 IUD Insertion 
 Data collection 
 Diary instructions 
 Gonorrhea/Chlamydia testing, if recommended per PPAU STI screening protocols 
1 Month Follow-Up  
 The 1 month follow-up appointment will be made on the day of enrollment.  Urine 
pregnancy test and confirmation of IUD position will be conducted at the clinic.  An 
IUD string check may also be performed.      
o Participants will be asked to complete a home pregnancy test on the day before 
their 1 month clinic visit that will be given to them at their enrollment 
visit.  They will be asked to take a picture of the pregnancy test results and text 
the results picture to a dedicated Planned Parenthood clinic cell phone (number 
will be provided at the time of enrollment).  This at-home testing will be 
confirmed at the in-clinic appointment as a proof-of-concept to establish this as 
a norm for future studies with the goal of reducing participant burden.    
 The following information will also be obtained either at the 1 month follow-up 
appointment or by phone, text, or email link to an online data collection instrument for 
those participants not able to return to clinic for the 1 month follow-up.   
o Bleeding history 
o Sexual activity 
o Data collection including evaluation of satisfaction of method chosen, current 
use of contraception and review for potential adverse events 
 If urine pregnancy test is positive, the following will occur:   
o Ultrasound and/or serum quantitative hCG pregnancy test as necessary to date 
the pregnancy (this will be completed at the Planned Parenthood Clinic Lab) 
o Removal of IUD 
o Follow-up throughout remainder of pregnancy 
o Pregnancy options counseling and appropriate referral for pregnancy care based 
on desire to continue or terminate the pregnancy. 
3, 6, and 9 months after enrollment 
 Telephone, text, email links to online survey or completion with a research assistant by 
telephone, text, or email (based on participant preference) 
 Review for potential adverse events 


 
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 Review of bleeding experience, questionnaire review including: unplanned pregnancy, 
abortion, sexual activity, IUD complications, contraception related side effects, 
participant clinic visits, use of condoms, employment status, income, school 
attendance and satisfaction with contraception method 
 12 months after enrollment (return visit) 
 Urine pregnancy test (Completed at the Planned Parenthood Clinic Lab). 
 IUD  string check. 
 Review for potential adverse events. 
 Review of bleeding experience, questionnaire review including unplanned pregnancy, 
abortion, sexual activity, IUD complications, contraception related side effects, 
participant clinic visits, use of condoms, employment status, income, school 
attendance, and satisfaction with contraception method. 
 If participant cannot come to the clinic for their for 12-month visit, they will be 
contacted by a research assistant for review of follow-up information (bullet point #4 
above) which can be completed via telephone, text, or email links to an online survey 
(based on participant preference).  The study team will also provide participants with a 
urine pregnancy test they can take at home (if unable to come into the clinic for this 
final visit) and ask that participants send the results of the home-urine pregnancy test to 
the study team via email, phone or text.   
**Note:  We have provided specifics about the questionnaires/surveys that will be asked of 
participants under each of the study procedure sections.  It is our understanding that we are not 
required to submit full versions of the surveys to the IRB, as long as we have provided 
thorough descriptions of what will be asked of participants.  
PI Conflict of Interest Management Plan 
The PI has met all requirements of the COI Management Plan, as follows: 
I will provide annual reports of my compliance with this management plan to the Conflict of 
Interest Office for review. 
I will disclose my financial conflict(s) of interest to the editors of all publications (journals, 
books, etc.) when submitting manuscripts or other reports of the results of this research. 
I will disclose my financial conflict(s) of interest in all public presentations of this research. 
The University of Utah will disclose my financial conflict(s) of interest on a publicly available 
web site. The publicly available disclosures will include my name, the name of the business 
entity(ies), the nature of the financial interest(s) and the dollar ranges or value of the financial 
interest(s) as available. 
I will disclose my financial conflict(s) of interest in writing to all members of the research team.
Members of the research team will be informed that if they have any concerns about my 
conflict(s) of interest, they can discuss those with the Individual Conflict of Interest Committee.
I will disclose my financial conflict(s) of interest in writing to all subordinates working on this 
project. Subordinates will be informed that if they have any concerns about my financial 


 
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conflict(s) of interest, they can discuss those with the department chair or the Individual 
Conflict of Interest Committee. 
My evaluation of University subordinates will not be based, in whole or in part, on their 
participation (or refusal to participate) in non-University activities involving any business entity 
in which I have significant financial interest(s) as defined by the University Individual Financial 
Conflict of Interest Policy. The participation of subordinates in non-University activities 
involving such business entities will not be expected or required. 
I will disclose my financial conflict(s) of interest in writing to all students working on this 
project. Students will be informed that if they have any concerns about my financial conflict(s) 
of interest, they can discuss those with their department chair, the chair of their graduate 
committee or the Individual Conflict of Interest Committee. 
My evaluation of University students will not be based, in whole or in part, on their 
participation (or refusal to participate) in non-University activities involving any business entity 
in which I have significant financial interest(s) as defined by the University's Individual 
Financial Conflict of Interest Policy. The participation of students in non-University activities 
involving such business entities will not be expected or required. 
Publication of student, subordinate, or other investigator's work on the project will not be 
delayed beyond the standard University agreement for review of intellectual property issues. 
I will promptly disclose any and all new intellectual property arising from this research to the 
University of Utah Technology & Venture Commercialization. 
I will identify a non-conflicted peer subject to the approval of the Individual Conflict of Interest 
Committee to review the research and results prior to publication. 
I will disclose my financial conflict(s) of interest to all potential research participants in the 
informed consent documents. 
A member of the research team who does not have any conflicts of interest related to this 
research or an appropriate third party will inform potential research participants of my financial 
conflict(s) of interest during the informed consent process. 
I will recuse myself from participation in the process of obtaining informed consent from all 
potential research participants for this study. Informed consent for all potential research 
participants will be obtained by a member of the research team who does not have any conflicts 
of interest related to this research or by an appropriate third party approved by the Individual 
Conflict of Interest Committee. 
  
 
 
Procedures performed for research purposes only:  
Randomization, for those participating in that arm of the study, is distinct from the us
clinical care that is provided at participating clinics. In addition, the use of a LNG IUD 
alone for EC is unique to the study and is not currently offered at the clinics.  
 
 
 
Statistical Methods, Data Analysis and Interpretation 
 


 
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Sample Size and Randomization:  There are two arms to the study.  The main study is a 
randomized controlled trial with non-inferiority design and participants will be assigned 1:1 to 
either the copper T380 IUD or the LNG20 IUD for EC. The non-inferiority margin is 2.5% 
and we assume a pregnancy rate of 0.1% for copper IUD EC users and a 1% EC pregnancy 
rate for LNG IUD users.   This estimate, based on our current COLIEC study (IRB# 50483) is 
conservative, falling within the 95% confidence interval (CI) of 0%-5.2% of the pregnancy 
rate of LNG20 IUD plus oral LNG for EC users. To achieve 80% power to detect a two-
sided 95% CI around the EC pregnancy incidence, a percent difference that does not 
cross the 2.5% noninferiorty margin, will require 335 participants per study arm (total 
of 670). We will recruit an additional 5%, 36 participants, (total of 706) to accommodate 
for potential early loss to follow up. Five percent is a conservative estimate based on our 
prior successful IUD EC studies. Even with obtaining multiple points of contact information 
and testing them prior to enrollment this can be a difficult population to maintain contact with. 
In our prior EC studies at 1 month we lost contact with 12 of 218 (5.5%) IUD users in our 
copper T IUD vs. oral LNG study and 8 of 176 (4.5%) in the COLIEC study. The use of the 
2.5% noninferiority margin is within confidence intervals of previous literature for pregnancies 
among oral LNG users, which is one of the clinical standards of care (1.7%; 95% CI 0.8%-
2.6%) (76) and the continued protection against future unintended pregnancy explored in aim 2 
makes this clinically acceptable. In addition, women who currently present for EC and decline 
a copper IUD are left with a choice of oral EC, which also falls within this confidence interval. 
While approaching the higher limit of the oral LNG per cycle pregnancy rate from the 
aforementioned study, it is well below per cycle pregnancy events in some subpopulations 
using oral LNG, which can result in pregnancy events of 5.8% for women with higher BMIs 
(>30BMI) and 7.3% in women who have additional unprotected sexual intercourse(28).  The 
LNG20 IUD is not affected by BMI and offers protection against pregnancy following future 
intercourse. 
The maximum number of participants in the entire study is 706.  
If recruitment is not adequate with this design and potential participants report concern about 
randomization as a reason for non-participation then a patient-preference cohort (PPC) will be 
offered to interested and qualified individuals.  
All women presenting to participating clinics when study participation is offered will be 
presented with a study information sheet, which includes an assessment of interest in the 
study.  If we find that we are not able to meet recruitment goals (e.g. <80 participants enrolled 
in the first 6 months) and the reason for non-participation is assessed to be lack of willingness 
to be randomized to the study interventions, then we will add an option for a PPC.  Should the 
PPC be introduced then participants who are interested in the study and eligible for 
participation but not willing to be randomized will be offered participation through the 
PPC. While 90% of EC users enrolled in a current study where they can choose their IUD type 
stated they would be willing to be randomized to either type of IUD, some individuals may be 
reluctant to agree to random assignment.  This potentially impacts result generalizability. In 
order to evaluate the magnitude and direction of non-participation bias we will offer eligible 
women presenting for EC who desire an IUD but are not willing to undergo randomization 
participation in a patient-preference cohort (PPC).   Participants in the PPC may choose the 


 
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IUD they desire.  The PPC will allow us to ascertain selection bias due to RCT non-
participation.  
Outcomes 
Primary Outcome:  Emergency contraception failures in both arms as assessed by positive 
urine pregnancy tests (HCG >25 IU) 4 weeks after having the IUD inserted. 
Secondary Outcomes:  
one-year unintended pregnancy rates 
Assess the one-year continuation, satisfaction, pain, and bleeding patterns of a LNG20 IUD to 
a copper T380 IUC as a method of EC 
 Pregnancy rates in the first year after presenting for EC 
 Timing of IUD insertion relative to time in the menstrual cycle (pre-ovulatory, 
ovulatory, post-ovulatory) 
 Unplanned pregnancy rates in the first year after presenting for EC 
 Effect of IUD choice on vaginal bleeding assessed monthly by Pictorial Blood 
Assessment Chart 
 Infections 
 IUD continuation, expulsions, and removals through the first year after presenting for 
EC 
 Satisfaction with EC method and contraception chosen 
 Sexual satisfaction at baseline and through the first year after presenting for EC 
 Frequency of unprotected intercourse since presenting for EC 
 Use of contraception in the year following presentation for EC 
 New diagnosis of any STI 
 IUD related complications 
 Abortion 
 Contraception related side effects 
 Use of a barrier method for prevention of sexually transmitted infections  
Data Analyses:  
The primary objective will be tested by non-inferiority design to test the hypothesis that the 
LNG IUD is no worse than the copper IUD with a noninferiority margin of 2.5%. Using 
Blackwelder’s approach for equivalence testing,[8] comparing those who become pregnant 
during the menstrual cycle in which their study IUD was inserted. Noninferiority will be 
established if the lower bound of a two-sided 95% CI does not cross the noninferiority bound. 
Analysis will be by intention to treat. 
For objective #2, comparison of one-year unintended pregnancy rates from women initiating 
the levonorgestrel IUD vs. copper T380 IUD for EC, will be assessed by Kaplan-Meier 
estimates. This same approach will be utilized to construct estimates of the proportion of 
patients who continue with their selected IUD for 1 year (continuation 


 
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proportion).  Continuous variables will be assessed by t-tests and discrete variables by Chi-
square testing as appropriate. 
All data will be analyzed using Stata statistical software (College Station, Texas).  Standard 
quality control methods will be employed including use of an independent data safety monitor. 
 
 

ICF_001.pdf: 
David Turok, MD (IRB# 73554) 
 
Page 1 of 10 
RAPID EC:  RCT Assessing Pregnancy with Intrauterine Devices for Emergency Contraception 
November 25, 2019 
FOOTER FOR IRB USE ONLY 
Version: 102513 
 
 
University of Utah 
Institutional Review Board 
Approved 11/26/2019 
Expires 3/26/2020 
IRB_00073554 
 
 
Consent and Authorization Document 
 
BACKGROUND 
You are being invited to take part in a research study. Before you decide it is important for you 
to understand why the research is being done and what it will involve. Please take time to read 
the following information carefully and discuss it with friends and relatives if you wish. Ask us if 
there is anything that is not clear or if you would like more information. Take time to decide 
whether or not you want to volunteer to take part in this research study.   
 
This study is being conducted by Dr. David Turok, a doctor who works with Planned Parenthood 
and at the University of Utah.  This study is sponsored by the National Institutes of Health (NIH) 
and is not sponsored by any commercial company.  Dr. Turok serves on advisory boards and 
receives research funding from three of the companies who make IUD’s that may be used in 
this research study.  This financial interest has been reviewed by the University of Utah Conflict 
of Interest Committee and is being managed under their oversight.  If you have questions, 
please ask Dr. Turok for more information. 
 
 
You are being asked to participate in this study because you came to Planned Parenthood 
looking for emergency contraception (EC) birth control in the first 5 days after unprotected sex.  
Plan B and Ella (also known as the morning after pill) are the most commonly used types of EC. 
They work very well to lower the risk of pregnancy after sex without contraception but they don’t 
do anything to prevent pregnancy for the future. Because women taking EC often also want to 
start a regular method of contraception we will explain two things for each birth control method 
we mention: #1) how well it works to lower the risk of pregnancy after sex without contraception 
(this means how well it works for EC) and #2) how well it works to prevent pregnancy in the 
future.  
 
An IUD (intrauterine device) is a small, T-shaped piece of plastic that is placed inside the uterus 
to prevent pregnancy. An IUD is the most effective method of reversible contraception, that is, it 
works well to prevent pregnancy when it is inside the uterus, but your ability to get pregnant 
returns after it is removed. Studies show that women who use IUDs are the most satisfied 
among all people using birth control.   
 
This research study will help us evaluate how well two IUDs work to lower the risk of pregnancy 
and how satisfied women are with these IUDs when they are placed for EC. Both IUDs work 
very well to prevent pregnancy when used as a regular birth control method. We know one IUD 
works extremely well when used to lower the risk of pregnancy after unprotected sex (for EC) 
and we think the other IUD may work for EC but it has not been tested alone for this. Below is a 
brief description of the IUDs we are comparing in this study:   
 
The copper IUD (ParaGard®) 
• 
#1) Among all methods of EC this IUD is the very best to keep you from getting pregnant 
if you have had sex within the last 5 days without using contraception (if 1000 women 
have sex and have this IUD placed 0-1 will get pregnant within the next month). 


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• 
#2) In the first year you use the copper IUD as a regular contraceptive, about 8 in 1000 
women will have a pregnancy.  
• 
It does NOT have hormones 
• 
It can last up to 12 years. You will have regular periods, but they may be heavier and 
you may experience more cramping. 
 
The hormonal IUD (LNG 52mg IUD, commonly known as Mirena® or Lilleta®) 
• 
#1) We think this IUD may work about as well as the morning after pill for EC, but we are 
not sure. If this IUD works as well as the morning after pill, then if 1000 women have sex 
without using birth control and have this IUD placed within 5 days, we expect that about 
20 will get pregnant in the next month. 
• 
#2) In the first year you use the hormonal IUD as a regular birth control method, about 2 
in 1000 women will have a pregnancy.  
• 
This IUD contains a hormone (a progestin called levonorgestrel) 
• 
It can last up to 3-5 years 
• 
Bleeding can be irregular in the first 3-6 months.  After that you will have less bleeding 
during your period, or no period at all.   
 
Because you won’t know which IUD you have for the first month, you will need to use a backup 
method of contraception (like condoms or not having sex) for the first 7 days after the IUD is 
placed in order to avoid pregnancy.  
 
We believe that both IUDs will lower your chance of pregnancy today and will continue to 
provide highly effective contraception for as long as you have the device.  In the long-term, both 
IUDs work as well as getting your tubes tied at preventing pregnancy.  It works for as long as 
you want (up to 3-5 years for the hormonal IUD or 12 years for the copper IUD).  You can have 
either IUD taken out at any time.  During the study, if you would like to switch to the other IUD 
you can do this at any time. The study will pay to remove and replace the new device.  
 
It is up to you to decide whether or not to take part in this study. If you decide to take part you 
are still free to withdraw at any time and without giving a reason. Refusal to participate or the 
decision to withdraw from this study will involve no penalty or loss of benefits to which you are 
otherwise entitled. If you don’t take part, you can still receive all standard care that is available 
to you. This will not affect the relationship you have with your doctor or other clinical staff, nor 
decrease the standard of care that you receive as a patient. 
 
STUDY PROCEDURES 
If you agree to participate in the study, your participation will include 2-3 clinic visits and 
completion of 3-4 online surveys over the 12 months you are in the study.  We may also use 
some information we collect from you in this study for other research projects about women’s 
contraception and pregnancy. 
 
Before you can enter this study, you must be: 
 
• 
between 18-35 years old 


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• 
in need of EC (had unprotected intercourse in the last 120 hours/5 days) 
• 
fluent in English and/or Spanish 
• 
willing to comply with study guidelines 
 
AND 
 
• 
have had a regular menstrual cycle (period every 21-35 days) over the last 3 months 
• 
know your last menstrual period (±3 days) 
• 
desire to prevent pregnancy for at least 1 year 
• 
have a working phone (that we will test today) and be willing to provide the names and 
contact information of 2 other people who always know how to contact you.  
 
Randomization 
If you meet all of the qualifications above and you agree to participate, you will be randomly 
assigned (like flipping a coin) to receive either: 
 
• 
The copper IUD  
 
or   
 
• 
The hormonal IUD 
 
You have an equal chance (50%) of being assigned to either IUD.  In other words, for every 100 
women who join the study, 50 women will receive the copper IUD and 50 women will receive the 
hormonal IUD.  This assignment (randomization) will occur while you are here at the clinic, 
immediately before you receive your IUD.   
 
This is a blinded study and that means you will not know which IUD you have until you return for 
your 1 month follow up visit. At that time we will tell you which IUD you received.  
 
If you do not return for your 1 month clinic visit and you want to know which IUD you have, you 
can call the clinic where you had the IUD inserted and they can tell you.  This information can 
be given to you more than 1 month after your initial insertion date. If you go to any health care 
provider who inserts IUDs, they will be able to tell you which IUD you have by doing a speculum 
exam and looking for the IUD strings (each IUD has different color strings).  
 
If you wish to change to the other kind of IUD, this can be done at any time during the year of 
study participation. Removing the IUD and replacing the other IUD will be paid for by the study 
for the period of time you are participating in the study.  
 
If you choose to have your IUD removed for any reason during your participation in the study, 
please contact the clinic.  We will arrange to have the IUD removed at a Planned Parenthood 
clinic at no cost to you. If you wish to change to another form of contraception, the clinic can 
help you get that birth control method. However, if you choose another type of birth control that 
will not be paid for by the study. 
 


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If your study IUD falls out please contact the clinic.  If you would like another IUD we will 
arrange for a new IUD insertion at a Planned Parenthood clinic.  This will be paid for by the 
study, if the IUD falls out within the first 3 months of your participation in the study. 
 
The specifics of the study visits and follow-up are listed below.   
 
Screening and Enrollment 
Before your IUD can be placed you will need to have a urine pregnancy test.  Once you ask any 
questions you may have and decide to be part of this study, you will be asked to sign this 
consent form and then have the IUD placed.   
 
Placing the IUD involves a vaginal speculum exam (like a Pap smear).  After this the cervix will 
be cleaned with soap, some local anesthetic may be placed in the cervix, and the IUD will be 
placed in your uterus.  
 
We will ask you to complete a questionnaire about prior sexual activity, use of contraception, 
pregnancies and sexually transmitted infections.   
 
When you leave the clinic on the first day we will give you a home urine pregnancy test to take 
home with you to use in 1 month.  
 
1 month after you have your IUD Inserted 
1 month after you have the IUD inserted we will ask you to do some things at home the day 
before you come back to clinic for your 1 month follow up visit. We will ask you to complete a 
home pregnancy test (which we will give to you today), take a picture of the result, and text the 
picture of the pregnancy test to a phone number we will provide to you. If you do not want to do 
this, or do not have a phone that can send images, then you won’t do this testing at home.   
 
All study participants will come in for a 1 month clinic visit.  During this clinic visit we will do a 
urine pregnancy test and if you desire or if your medical provider recommends, you may have 
an exam to check for your IUD strings.  We will update your contact information, check on any 
side effects and symptoms, ask about bleeding, or if you are having any problems.  We will also 
ask you about how much you like the method of contraception you are using. 
 
Follow-Up Questionnaires (Telephone, Text or Email) 
We will contact you at 3, 6, and 9 months after the IUD was placed to ask you to complete a 
study survey.  The survey can be done either online or over the phone, depending on your 
preference.  The survey will ask questions about: sexual activity, contraception and pregnancy.  
There will also be a few questions about your income and whether or not you are currently in 
school. We do everything we can to keep your answers to the survey private.  We explain more 
about the ways we do this later on in the consent.   
 
12-Month Study Visit 
Twelve months after the IUD is placed we will ask you to come to the Planned Parenthood clinic 
for your final study visit.  This visit will include a urine pregnancy test, and if you desire or if your 
medical provider recommends, you will have a pelvic exam to confirm that your IUD is still in 


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place.  And, we will review any side effects that you may have had, including bleeding. We will 
also ask you about how much you like the method of contraception you are using. If you are 
unable to meet in person for this visit you can complete the survey online or over the phone, 
depending on your preference.   
 
The total length of your involvement in the study is 12 months.  If you get pregnant at any time 
within a year of starting the study, we will contact you to find out the outcome of the pregnancy.  
This may require us contacting you up to 22 months from today to see what happened with the 
pregnancy. We will verify the outcome of any pregnancy by checking the University of Utah for 
any birth records or Utah State birth certificate records.  Keeping in touch with you is very 
important for the next year. If you wish to contact us at any time you can contact us by 
email or phone (call or text) or on Facebook through private messages.  We will give you a 
card with this information and send you an email today. 
 
RISKS 
While the copper IUD is extremely safe and effective for both EC and for preventing pregnancy 
for the long term, it is not FDA approved for EC.  Use of either IUD for EC is considered “off-
label” (this means that it is used for another purpose in addition to ones initially approved by the 
FDA). Many medicines that are prescribed by doctors and used safely everyday are used “off-
label.”   
 
The American College of Obstetricians and Gynecologists, the leading doctor’s group of 
women’s health care providers, recommends using the copper IUD for EC. The risk of 
pregnancy in the month after having a copper IUD placed (ParaGard®) for EC is 1/1000.   
 
We are not certain about how well the hormonal IUD works as EC but we believe that the risk of 
pregnancy is about the same as for women who use EC pills, 20/1000 or less.  This is based on 
a study of 105 women at high risk of pregnancy who got both the hormonal IUD and EC pills 
and there were no pregnancies from EC failure. So, we believe that the hormonal IUD has some 
EC effect by itself. 
 
If a pregnancy does occur while the IUD is in place there is an increased risk of having a 
miscarriage. If you are pregnant with the IUD in place it should be removed immediately.  If the 
IUD remains in place during a pregnancy there is a higher risk of infection or early delivery. If 
you have a pregnancy with an IUD in place you should be evaluated for an ectopic pregnancy 
(tubal pregnancy) as soon as possible. While the overall risk of pregnancy is very low with both 
IUDs, if there is a pregnancy does happen with an IUD in place, you are more likely to 
experience an ectopic pregnancy than you would without an IUD. 
 
Putting in the IUD is a simple procedure, similar to getting a Pap smear. 
 
The risks of having an IUD inserted are: 
 
• 
Mild cramping at the time of insertion. 
• 
Risk of IUD falling out. This happens rarely (about 5% of the time). You may have 
increased cramping and heavy bleeding if your IUD is falling out. If you notice these 


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symptoms or see your IUD come out, we want you to call us. We can replace it in the 
clinic. Remember that if it isn't in your uterus, it cannot keep you from getting pregnant. 
• 
Risk of change in bleeding patterns.  People with both kinds of IUDs can have irregular 
bleeding within the first month of insertion. You do not need to see a medical provider for 
this unless it is very heavy and causes you to worry. In that case please call or return to 
the clinic to discuss this with a clinician.   
• 
Women with the copper IUD have a little heavier bleeding or an additional day of 
bleeding with their periods. After getting this type of IUD, most women's menstrual 
periods return to normal within 3-6 months. Women who have the hormonal IUD inserted 
can have very irregular bleeding for the first 3-6 months and then have very little or no 
bleeding after that time period.   
• 
IUDs protect against pregnancy. They do not protect against sexually transmitted 
infections such as Chlamydia or HIV. If you are having sex with more than one person, 
or with someone who has HIV, or is having sex with other people besides you, condoms 
are the only way to protect yourself from infection.  
• 
When the IUD is being inserted it is possible to place the IUD or other instruments 
through the wall of the uterus.  This is called uterine perforation and happens about once 
in 1000 insertions.  If that happens you will not be able to have an IUD at this time.   
• 
The copper IUD contains copper. Therefore, women who have an allergy to copper or 
Wilson's disease cannot have this IUD. If you have any treatments in the future that 
might be affected by copper, like heat treatments or MRI, tell your doctor first. 
• 
Women using the two different IUDs in this study may experience other rare side effects. 
These may be different for the different IUDs. Since some of these can be serious 
please discuss any concerns you have about possible side effects with the staff at this 
clinic or your regular medical provider. 
 
Completing questionnaires and talking about your sexual history may occasionally be stressful, 
uncomfortable or embarrassing.  You do not have to answer any questions or do anything that 
makes you uncomfortable.  There is also a small risk of loss of privacy, but we make every effort 
to reduce those risks.   
 
UNFORESEEABLE RISKS 
In addition to the risks listed above, you may experience a previously unknown risk or side 
effect. 
 
BENEFITS 
If you choose to participate in this study and have an IUD inserted, the IUD will protect you from 
pregnancy for up to 12 years for the copper IUD and 3-5 years for the hormonal IUD.  You can 
decide how long you would like to leave it in.  A benefit to participating in the study is that you 
will not be charged for your choice of EC (this includes either the copper IUD or the hormonal 
IUD).  The information we get from this study may help us to treat future patients requesting 
emergency contraception.  
 
ALTERNATIVE PROCEDURES 


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You may choose not to be in this study. If you choose not to be in this study, the clinic staff will 
assist you in getting some method of contraception. If you want an IUD for contraception but do 
not want to participate in the study it can still be done here at the clinic.   
 
 
 
PERSON TO CONTACT 
If you have questions, complaints or concerns about this study, or if you think you may have 
been injured from being in this study, you can contact Dr. David Turok or one of his partners 24 
hours/day at the University of Utah at (801)581-6170.   
 
Institutional Review Board: Contact the Institutional Review Board (IRB) if you have questions 
regarding your rights as a research participant. Also, contact the IRB if you have questions, 
complaints or concerns which you do not feel you can discuss with the investigator. The 
University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at 
irb@hsc.utah.edu.   
 
Research Participant Advocate:  You may also contact the Research Participant Advocate 
(RPA) by phone at (801) 581-3803 or by email at participant.advocate@hsc.utah.edu.  
 
RESEARCH-RELATED INJURY 
If you are injured from being in this study, medical care is available to you at the University of 
Utah Hospital, as it is to all sick or injured people. The University of Utah has not set aside any 
money to pay the costs for such care. The University will work with you to address costs from 
injuries. Costs would be charged to you or your insurance company (if you have insurance), to 
the study sponsor or other third party (if applicable), to the extent those parties are responsible 
for paying for medical care you receive. Since this is a research study, some health insurance 
plans may not pay for the costs. By signing this consent form you are not giving up your right to 
pursue legal action against any parties involved with this research. 
 
The University of Utah is a part of the government. If you are injured in this study, and want to 
sue the University or the doctors, nurses, students, or other people who work for the University, 
special laws may apply. The Governmental Immunity Act of Utah is a law that controls when a 
person needs to bring a claim against the government, and limits the amount of money a person 
may recover. See sections 63G -7-101 to -904 of the Utah Code. 
 
The University of Utah and Planned Parenthood Association of Utah (PPAU) are both providing 
services to you as part of this study.  Each service provider is only responsible for the services 
that they actually perform. 
 
VOLUNTARY PARTICIPATION 
Research studies include only people who choose to take part.  You can tell us that you don’t 
want to be in this study.  You can start the study and then choose to stop the study later.  We 
will still give you medical care and answer any questions you have.  Your decision will not affect 
your relationship with your doctor or the study team in any way.  
 


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RIGHT OF INVESTIGATOR TO WITHDRAW 
The investigator can withdraw you without your approval. Possible reasons for withdrawal 
include deciding you do not want an IUD. 
 
COSTS AND COMPENSATION TO PARTICIPANTS 
There are no costs to you for participating in this research study.  You will receive either a 
copper or hormonal IUD at no cost to you.  You will also receive compensation for your 
participation in the study, as follows: 
 
• 
$40 electronic gift code will be sent to you after you complete your 1 month follow up 
visit and survey; 
• 
$10 electronic gift code will be sent to you after you complete each of the 3, 6 and 9-
month surveys; 
• 
$40 electronic gift code will be sent to you after you complete your final 12-month clinic 
visit and survey.   
 
If you do not come in to the clinic for your 1-month or 12-month clinic visits, but you do complete 
the online surveys, you will receive $10 gift codes for each of those visits, instead of $40 for 
each visit.   
 
NEW INFORMATION 
Sometimes during the course of a research project, new information becomes available about 
the treatment that is being studied.  If this happens, your research doctor will tell you about it 
and discuss with you whether you want to continue in the study.  If you decide to withdraw, your 
research doctor will make arrangements for your care to continue.  If you decide to continue in 
the study, you will be asked to sign an updated consent form.  Also, on receiving new 
information your research doctor might consider it to be in your best interests to withdraw you 
from the study. He/she will explain the reasons and arrange for your care to continue.  
 
NUMBER OF PARTICIPANTS 
We expect to enroll up to 850 participants for this study at Planned Parenthood Clinics in Utah.  
 
AUTHORIZATION FOR USE OF YOUR PROTECTED HEALTH INFORMATION  
Signing this document means you allow us, the researchers in this study, and others working 
with us to use some information about your health for this research study. 
 
This is the information we will use and include in our research records:  
- 
Demographic and identifying information like name, address, telephone number and 
email address; 
- 
Contact information for 2 people who can always contact you; 
- 
Related medical information about you like:  current or past medications or therapies, 
prior illnesses, surgeries or pregnancies, allergies, detail information about your 
recent periods; 


David Turok, MD (IRB# 73554) 
 
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- 
Information from a physical examination such as: blood pressure reading, heart rate, 
breathing rate, temperature, weight; 
- 
All tests and procedures that will be done in the study; 
- 
Answers to all phone or online surveys and completed in the study; 
How we will protect and share your information: 
 
• 
We will do everything we can to keep your information private but we cannot guarantee 
this. Study information will be kept in a secured manner and electronic records will be 
password protected. Study information may be stored with other information in your 
medical record. Other doctors, nurses, and third parties (like insurance companies) may 
be able to see this information as part of the regular treatment, payment, and health care 
operations of the hospital. We may also need to disclose information if required by law. 
 
• 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law.  This website will not include information that can identify you.  At 
most, the website will include a summary of the results.  You can search this website at 
any time. 
 
• 
In order to conduct this study and make sure it is conducted as described in this form, 
the research records may be used and reviewed by others who are working with us on 
this research: 
o Members of the research team at Planned Parenthood Association of Utah and 
University of Utah Health Sciences Center; 
o The University of Utah Institutional Review Board (IRB), who reviews research 
involving people to make sure the study protects your rights; 
o Twilio:  Your cell phone number will pass through Twilio when we send you an 
SMS text message allowing you to complete your follow-up surveys via text 
messaging.  Twilio will not have access to any information that identifies you 
other than your cell phone number and they will delete your cell phone number 
within 24 hours of when you receive the SMS message. 
o Utah State Department of Health: infectious diseases that were listed above will 
be reported to this state agency; 
o Food and Drug Administration:  a federal agency that needs to confirm the 
accuracy of the results submitted to the government. 
 
• 
If we share your identifying information with groups outside of Planned Parenthood 
Association of Utah or University of Utah Health Sciences Center, they may not be 
required to follow the same federal privacy laws that we follow.  They may also share 
your information again with others not described in this form. 
 
• 
If you do not want us to use information about your health, you should not be part of this 
research.  If you choose not to participate, you can still receive health care services at 
Planned Parenthood Association of Utah.   
 


David Turok, MD (IRB# 73554) 
 
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What if I decide to Not Participate after I sign the Consent and Authorization Form? 
You can tell us anytime that you do not want to be in this study and do not want us to use your 
health information.  You can also tell us in writing.  If you change your mind, we will not be able 
to collect new information about you, and you will be withdrawn from the research study. 
However, we can continue to use information we have already started to use in our research, as 
needed to maintain the integrity of the research.   
 
This authorization does not have an expiration date.   
 
FUTURE CONTACT 
From time-to-time we have studies that might be of interest to you.  Can someone from the 
University of Utah, Department of Obstetrics and Gynecology, contact you by phone/mail if we 
have a study in the future that may be of interest to you? 
 
_____Yes 
 
_____No 
 
CONSENT 
 
I confirm that I have read this consent and authorization document and have had the opportunity 
to ask questions. I will be given a signed copy of the consent and authorization form to keep. 
 
I agree to take part in this research study and authorize you to use and disclose health 
information about me for this study, as you have explained in this document. 
 
 
________________________ 
Participant’s Name 
 
 
________________________ 
 
 
 
 
____________ 
Participant’s Signature 
 
 
Date 
 
 
________________________ 
Name of Person Obtaining Authorization and Consent 
 
 
________________________ 
 
 
 
 
____________ 
Signature of Person Obtaining Authorization and Consent  
Date