Transdermal birth-control patch to stop irregular bleeding from contraceptive implants
Official title: Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users: A Randomized, Double-Blind, Controlled Trial
Run by Chulalongkorn University · NCT07083635 · Data updated 2026-11-12
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 | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Pathum Wan, Bangkok) |
| Status | Recruiting |
| Started | July 29, 2025 |
| Main results expected | September 2026 |
| Study ends | December 2026 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT07083635 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Family Planning Clinic, King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand Recruiting
Study contacts
- Study coordinator: Tunchanok Juntamongkol, M.D.
- Email: tunchanok.junt@gmail.com
- Phone: +6626494000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.