RAPID EC - Randomized Controlled Trial Assessing Pregnancy With Intrauterine Devices for Emergency Contraception
Phase: PHASE4
Conditions: Contraception
Sponsor: University of Utah

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 1 of 12 
 
IRB Approval 1/10/2022 
 
 
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.  
 
 

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 2 of 12 
 
IRB Approval 1/10/2022 
 
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: 

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 3 of 12 
 
IRB Approval 1/10/2022 
 
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. 

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 4 of 12 
 
IRB Approval 1/10/2022 
 
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 
  

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 5 of 12 
 
IRB Approval 1/10/2022 
 
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 

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 6 of 12 
 
IRB Approval 1/10/2022 
 
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 

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 7 of 12 
 
IRB Approval 1/10/2022 
 
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 

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 8 of 12 
 
IRB Approval 1/10/2022 
 
 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 

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 9 of 12 
 
IRB Approval 1/10/2022 
 
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 
 

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 10 of 12 
 
IRB Approval 1/10/2022 
 
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 

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 11 of 12 
 
IRB Approval 1/10/2022 
 
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 

 
Protocol Summary (ERICA) 
 
IRB_00073554 
Page 12 of 12 
 
IRB Approval 1/10/2022 
 
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.