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

NCT07083635 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-10

No results posted yet for this study

Summary

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

Conditions

  • Menstruation Disturbances
  • Metrorrhagia
  • Uterine Hemorrhage
  • Contraception Behavior

Interventions

DRUG

Transdermal Ethinyl Estradiol/Norelgestromin Patch

Transdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott.

DRUG

Placebo Patch

Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-29
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07083635 on ClinicalTrials.gov