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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 10, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Sep 2025 to Sep 2026
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2025 to Jul 29, 2025
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to evaluate the effectiveness of transdermal contraceptive patches in treating irregular vaginal bleeding in women over 18 years old who are using contraceptive implants and experiencing abnormal vaginal bleeding. The main questions it aims to answer are: * Does transdermal ethinyl estradiol and norelgestromin patch effectively treat irregular vaginal bleeding caused by contraceptive implants compared to placebo? * What proportion of participants will report cessation of vaginal bleeding during treatment and remain bleeding-free at day 14 of treatment? * What is the safety profile and adherence rate of the transdermal patch treatment? Researchers will compare participants receiving active hormonal patches (ethinyl estradiol 600 mcg + norelgestromin 6 mg) to those receiving placebo patches to see if the hormonal treatment effectively stops irregular vaginal bleeding. Participants will: * Apply transdermal patches for 21 days (changing patch every 7 days - total of 3 patches) * Attend follow-up visits at days 7, 14, 21, and 3 months (day 14 in-person, others via telephone) * Complete bleeding diaries and report any side effects * Follow-up schedule: Day 7: Telephone follow-up to assess bleeding pattern, side effects, and patch adherence Day 14: In-person visit at the clinic for comprehensive evaluation including bleeding assessment, side effects monitoring, and adherence check Day 21: Telephone follow-up to evaluate treatment completion, ongoing bleeding status, and need for additional treatment 3 months: Final telephone follow-up to assess long-term outcomes and recurrence of bleeding
Trial Details
NCT Number NCT07083635
Lead Sponsor Chulalongkorn University
Conditions
(from sponsor)
Menstruation Disturbances, Metrorrhagia, Uterine Hemorrhage, Contraception Behavior
Related terms Contraception Behavior, Menstruation Disturbances, Metrorrhagia, Uterine Hemorrhage
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov