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Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users
NCT07083635Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Sep 2026
- Countries
- 1
- Sponsor
- Chulalongkorn University
- Modality
- Orthosteric Ligands
- Conditions
- abnormal uterine bleeding (AUB)
01
Overview
Phase 2, randomised, double-blind trial of ethinyl estradiol and norelgestromin in abnormal uterine bleeding (AUB) (2 arms), sponsored by Chulalongkorn University. Primary endpoint: Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14. Started Jul 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Treatment
Transdermal Hormonal Contraceptive Patch (Ethinyl Estradiol 600 mcg and Norelgestromin 6 mg)
Placebo
Placebo Transdermal Patch
03
Who it enrols
Women aged 18+ with irregular vaginal bleeding caused by contraceptive implants, normal pelvic exam/ultrasound, and normal cervical cancer screening. Excludes those with recent treatment for bleeding, pregnancy, contraindications/allergies to estrogen/progestin, or heavy bleeding causing anemia symptoms.
04
Endpoints
Primary
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14
Secondary
Proportion of participants with at least 7 consecutive bleeding-free days during treatment month
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 7
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21
Number of days of treatment required before cessation of vaginal bleeding
Number of days of spotting/breakthrough bleeding during treatment
Number of days before recurrence of vaginal bleeding after treatment cessation
Treatment-related adverse events
Treatment adherence/compliance
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