Study of Transdermal Ethinyl Estradiol and Norelgestromin Patches to Treat Irregular Vaginal Bleeding in Women Using Contraceptive Implants

What this Trial Is About

Researchers are evaluating the use of transdermal contraceptive patches to treat irregular vaginal bleeding in women aged 18 years and older who are using contraceptive implants. The study aims to determine whether patches containing ethinyl estradiol and norelgestromin can effectively stop abnormal bleeding compared to placebo patches, and to assess the safety and adherence to this treatment. Key questions include the rate of bleeding cessation and how long participants remain free from bleeding during and after treatment. Participants are randomly assigned to receive either active hormonal patches with ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams or placebo patches that look identical but contain no hormones. Each participant applies one patch every 7 days for a total of 21 days, using three patches. Follow-up visits occur at days 7, 14, 21, and 3 months, with the day 14 visit conducted in person and others by telephone. During the study, participants keep bleeding diaries and report any side effects. Researchers monitor bleeding patterns, safety, and treatment adherence through telephone and in-person assessments. The main outcome measured is the proportion of women who stop vaginal bleeding during treatment and remain bleeding-free at day 14. Secondary outcomes include bleeding-free days during treatment, time to bleeding cessation, recurrence of bleeding after treatment, adverse events, and adherence over the 3-month follow-up period.

Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users