Etonogestrel Implant as Emergency Contraception (NCT05237141) | Clinical Trial Compass
RecruitingPhase 4
Etonogestrel Implant as Emergency Contraception
United States12 participantsStarted 2022-04-01
Plain-language summary
The investigators propose a single site, single arm, open label mechanism of action pharmacodynamic pilot study of etonogestrel implant insertion prior to an luteinizing hormone (LH) surge. The investigators will evaluate ovulation rates via serum levels of reproductive hormones and transvaginal ultrasound findings following placement of an etonogestrel implant once the dominant follicle reaches a size of 15mm or greater, but prior to an LH surge, in persons with prior documented regular cycles and confirmed ovulation. The researchers' hypothesis is that ovulation will be inhibited if the etonogestrel implant is placed prior to an LH surge.
Based on data from the Food and Drug Administration label for Nexplanon, etonogestrel rises to levels associated with ovulation suppression within 8 hours of placement. Given this rapid increase, it is therefore plausible to assume that ovulation can be inhibited by the implant if placed prior to an LH surge. This study is novel as there have been no published studies evaluating an etonogestrel implant for this indication.
The contribution of this proposed research to the literature is significant because current recommendations from the Center for Disease Control (CDC) regarding timing of etonogestrel implant placement are stringent and not patient-centered. Any day insertion of the etonogestrel implant is supported by retrospective data and this pharmacodynamic data would further support the literature for any day insertion without the need for additional emergency contraception. If results support the investigators' hypothesis, it could increase access to contraception and decrease duplicative therapy.
Who can participate
Age range
18 Years – 40 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:
* BMI less than or equal to 28kg/m2
* Intact uterus with at least one ovary
* Regular menstrual cycles that occur every 21-35 days
* If patient is postpartum or post-second trimester abortion, 3 menses (2 cycles) must have occurred prior to enrollment
* If patient had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment
* Desires insertion of an etonogestrel contraceptive implant for contraception
* Not currently pregnant or trying to become pregnant
* Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study
Exclusion Criteria:
* Have a known hypersensitivity or contraindications to etonogestrel.
* Medical conditions that affect liver function (e.g., hepatitis, cirrhosis; assessed via participant self-report)
* Known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the etonogestrel.
* Uncontrolled thyroid disorder.
* Use of long-acting injectable hormonal contraceptive within the past 9 months
* Current use of hormonal oral, patch, intravaginal, or intrauterine contraception
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.