Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg (NCT03537768) | Clinical Trial Compass
TerminatedPhase 4
Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg
Stopped: We weren't seeing as many pregnancies we initially thought.
United States532 participantsStarted 2018-07-12
Plain-language summary
The proposed research study is a Phase IIb, multi-center, single-blind, randomized study of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg to evaluate EC effectiveness in women with weight ≥ 80 kg who present within 72 hours of unprotected intercourse.
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
. Be in good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
. Between 18 and 40 years inclusive at the enrollment visit.
. Weight ≥ 80 kg.
. Have regular menstrual cycles that typically occur every 21-35 days when not using hormonal contraception.
. If subject is postpartum or post-abortal, she must have experienced a menstrual bleed since the pregnancy ended
. If a subject recently used non-injectable hormonal contraception, one bleeding episode consistent with menses must have occurred since last use;
. Willing to avoid use of any hormonal or intrauterine contraception until the end of the study;
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
Incidence of pregnancies of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg in women with weight ≥ 80 kg for emergency contraception (within 72 hours of unprotected intercourse).
. For women with a recent history of Depo Provera use, the most recent injection must have been at least 6 months before study entry, and the subject must have had at least one normal menstrual cycle (2 consecutive menses);
Exclusion criteria
. Be currently pregnant (positive high-sensitivity urine pregnancy test);
. Be currently breastfeeding or within 30 days of discontinuing breastfeeding, unless the subject has already had a menses following discontinuation of breastfeeding;
. Desire to use hormonal systemic contraception within 5 days of study drug use
. Have had a female sterilization procedure;
. Have a partner with a history of vasectomy;
. Current inability to tolerate oral medication;
. Have impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.