Transdermal birth-control patch to stop irregular bleeding from contraceptive implants

Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users: A Randomized, Double-Blind, Controlled Trial

This will test whether a 21-day transdermal ethinyl estradiol/norelgestromin patch can stop irregular vaginal bleeding in women aged 18 and older who use contraceptive implants.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Chulalongkorn University (other)
• Locations: 1 site (Pathum Wan, Bangkok)
• Trial ID: NCT07083635 on ClinicalTrials.gov

What this trial studies

Women aged 18 and older who use contraceptive implants and have prolonged or frequently recurring irregular vaginal bleeding are randomized to receive either an active transdermal patch (ethinyl estradiol 600 mcg + norelgestromin 6 mg) or a placebo patch for 21 days, changing the patch every 7 days. The primary outcome is the proportion of participants whose bleeding stops during treatment and who remain bleeding-free at day 14, with secondary monitoring of safety and adherence. Key eligibility requires normal pelvic exam and transvaginal ultrasound and excludes pregnancy, recent treatment for bleeding, heavy bleeding causing anemia, or contraindications/allergies to estrogen or progestin. The intervention is administered at the Family Planning Clinic of King Chulalongkorn Memorial Hospital in Bangkok under a phase 2 protocol led by Chulalongkorn University.

Who should consider this trial

Good fit: Women aged 18 or older who are current contraceptive-implant users experiencing bleeding for more than 8 consecutive days or frequent bleeding intervals (15 days or less) with normal pelvic imaging and no contraindications to estrogen are ideal candidates.

Not a fit: Women who are pregnant, have contraindications or allergies to estrogen/progestin, have had recent treatment for irregular bleeding, or have heavy bleeding causing anemia are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, the patch could rapidly stop bothersome implant-associated irregular bleeding and reduce the need for implant removal or additional procedures.

How similar studies have performed: Combined hormonal therapies have been used for progestin-only contraceptive–associated bleeding with mixed results, and there are limited trial data specifically using transdermal patches for implant-related irregular bleeding.

Eligibility criteria

Inclusion Criteria:

* Women aged 18 years and older
* Regular menstrual cycles : at least 1 cycle prior to contraceptive implant insertion
* Normal pelvic examination and transvaginal ultrasound results
* Normal cervical cancer screening within the past 3 years
* Irregular vaginal bleeding defined as: Bleeding for more than 8 consecutive days, or Bleeding-free intervals of 15 days or less

Exclusion Criteria:

* Previous treatment for irregular vaginal bleeding within the past 3 months
* Pregnancy
* Contraindications to estrogen or progestin use
* Allergy to estrogen or progestin
* Allergy to hormonal patches
* Heavy vaginal bleeding causing anemia symptoms such as: Fatigue/Fainting/Dizziness

Where this trial is running

Pathum Wan, Bangkok

• Family Planning Clinic, King Chulalongkorn Memorial Hospital — Pathum Wan, Bangkok, Thailand (RECRUITING)

Study contacts

• Study coordinator: Tunchanok Juntamongkol, M.D.

Conditions: Menstruation Disturbances, Metrorrhagia, Uterine Hemorrhage, Contraception Behavior, Contraceptive implant, Abnormal vaginal bleeding, Bothersome vaginal bleeding, Irregular vaginal bleeding