Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) v… (NCT06162611) | Clinical Trial Compass
RecruitingPhase 4
Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo
United States790 participantsStarted 2023-11-06
Plain-language summary
Intrauterine devices (IUDs) are highly effective to prevent pregnancy when used for emergency contraception (following unprotected intercourse in the last 3 days), but data are lacking for people who desire an etonogestrel (ENG) contraceptive implant in this situation. This proposal will identify the most effective way to start an implant for emergency contraception using a randomized controlled trial comparing pregnancy risk between those receiving the implant vs. the implant plus oral emergency contraception (EC). Data from this project will inform clinical practice and add another option, the implant, for those desiring a long acting, highly effective contraceptive method when they present for emergency contraception.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between 18-35 years old
* Unprotected intercourse within 72 hours
* Biologically capable of pregnancy (intact uterus without prior sterilization surgery
* Fluent in English and/or Spanish
* Have a regular menstrual cycle (21-35 days)
* Known last menstrual period (+/- 3 days)
* Working (cell) phone number
* Willing to comply with the study requirements
* Willing to abstain from any CYP3A4 inducer for 5 days
Exclusion Criteria:
* Current pregnancy (+urine pregnancy test in clinic)
* Breastfeeding
* Contraindication to ENG or LNG based on CDC MEC/SPR
* Sterilization, hysterectomy, or has an IUD or contraceptive implant in place
* Vaginal bleeding of unknown etiology
* Previous use of EC in same cycle
* Allergy to LNG or ENG
* History of intolerance/ side effects with ENG Implant
* Current (past 7 days) use of any CYP3A4 inducer
* Plan to use any other steroid hormone in the next 4 weeks (testosterone, estrogen, progesterone)
* Ended a pregnancy at or under 20 weeks gestational age within last 2 weeks
* Ended a pregnancy over 20 weeks gestational age in last 6 weeks
* Use of any injectable hormonal contraceptive (Depo-Provera) in the last 15 weeks
* Use of any oral EC, contraceptive pills, patches, vaginal rings, or an IUD or Implant in the last 2 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception
Timeframe: 1 month after enrollment
2
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception by BMI category
Timeframe: 1 month after enrollment
3
Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception
Timeframe: 1 month after enrollment
4
Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception by BMI category
Timeframe: 1 month after enrollment
5
Ovulation frequency within 5 days of implant insertion in the oral levonorgestrel arm
Timeframe: 5 days after implant insertion
6
Ovulation frequency within 5 days of implant insertion in the placebo arm