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 range18 Years – 40 Years
SexFEMALE
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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;
✓. 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
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).