Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbe… (NCT06672016) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential
United States1,630 participantsStarted 2025-01-13
Plain-language summary
The Sponsor is developing a progestin-only contraceptive transdermal system (patch).
The main purpose of this study is to look at how safe the study patch is and how well it works in preventing pregnancy. The study will also look at how well the study patch is tolerated.
The study patch is a transdermal system that contains the active ingredient, progestin.
Who can participate
Age range16 Years
SexFEMALE
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Inclusion criteria
✓. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age.
✓. Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1 year.
✓. Has negative UPT results at screening and at enrollment visits.
✓. Has normal, regular menstrual cycles that are between 21 and 35 days in duration over the last 6 months.
✓. Engages in regular heterosexual vaginal intercourse (at least once per cycle), with a partner who is not known to be sub fertile or infertile.
✓. Agrees not to use other contraceptives or other methodology to prevent pregnancy during the study.
✓. Able to understand and voluntarily provide written informed consent or assent (if the participant is adolescent prior to undergoing any trial related procedure) to participate in the study.
Exclusion criteria
✕. Known or suspected pregnancy or planning pregnancy during next 12 months.
✕. Participants with known hypersensitivity or intolerance to progestins, or any components of the progestin patch.
✕. History or presence of dermal sensitivity to medicated patches or to topical applications including bandages, surgical tape.
✕. Known infertility (current or known history) or history of sterilization in either partner.
What they're measuring
1
To determine the contraceptive efficacy of progestin only patch when used over 13 cycles
✕. Received injectable hormonal contraceptive therapy within 10 months of study enrollment.
✕. Current use of hormonal contraceptive implants.
✕. Has non-hormonal or hormonal intrauterine device (IUD) in place; or has had a recent IUD removal without one spontaneous menses after removal prior to the date of enrollment.
✕. Recent surgical or medical abortion, miscarriage, ectopic pregnancy, or vaginal or cesarean delivery.