Ovarian Function With ENG Implant and UPA Use (NCT04291001) | Clinical Trial Compass
CompletedEarly Phase 1
Ovarian Function With ENG Implant and UPA Use
United States40 participantsStarted 2020-09-04
Plain-language summary
Same day initiation of the etonogestrel (ENG) implant and oral ulipristal acetate (UPA) would overcome contraceptive access barriers to people capable of pregnancy with recent unprotected intercourse to ongoing contraception. Current clinical guidelines recommend delaying implant initiation for at least 1 week following UPA, as well as waiting 7 days before relying on the implant for contraception after initiation alone. This pilot will assess the effects of the implant alone and the implant inserted with same-day as UPA usage on ovarian activity. A total of 40 people capable of pregnancy desiring the implant, who are not at risk for pregnancy during the study timeline, will be recruited. Participants will be randomized to implant alone or same-day implant + oral UPA. Participants will have daily ultrasounds and blood draws to assess timing of ovulation for 1 week and then an exit visit at 14 days after randomization. The primary outcome is the incidence of ovulation in the 2 randomized treatment groups. Participants may continue the implant after the study per FDA guidelines and rely on it for contraception after the study is completed.
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:
* Healthy females, age 18-35
* Fluent in English
* BMI \< 30 kg/m2
* No known contraindication to either the ENG contraceptive implant or Ulipristal Acetate (UPA) using the CDC Medical Eligibility Criteria for Contraceptive Use 2016
* Not current pregnant and not at risk of pregnancy (defined as not having penile-vaginal intercourse or using a non-hormonal method of contraception such as a barrier method, condoms, diaphragm, or cervical cap, a copper IUD, or permanent contraception)
* Know the date of last menstrual period
* Have a regular menstrual cycle (24-35 days)
* Be willing to comply with all study requirements
* Be willing to avoid pregnancy for the duration of the study
Exclusion Criteria:
* Currently pregnancy or breastfeeding
* Use of hormonal contraception or exogenous hormones (estrogen, progestogen, or HCG) in the last month (or past 6 months for depo medroxyprogesterone acetate) or planned use of such during the study
* Vaginal bleeding of unknown etiology
* Allergy to UPA or ENG
* Regular or planned use of glucocorticoids during the study
* Current or planned use of any medication that potentially interacts with UPA or ENG
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
Number of Participants With Ovulation With Implant-alone
Timeframe: 5 days
2
Number of Participants With Ovulation With Implant and Same Day UPA