A Phase 2 interventional study of Transdermal Ethinyl Estradiol/Norelgestromin Patch and Placebo Patch in Menstruation Disturbances, Metrorrhagia and Uterine Hemorrhage, sponsored by Chulalongkorn University. Recruiting at 1 site in Thailand. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Chulalongkorn University · Phase 2, Interventional, and Treatment
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:
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:
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
105 studies on the registry are indexed under Menstruation Disturbances; 23 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 67 interventional studies indexed under Menstruation Disturbances.
Browse Menstruation Disturbances studies →Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transdermal Hormonal Contraceptive Patch (Ethinyl Estradiol and Norelgestromin) Active Ingredients: Ethinyl Estradiol: 600 micrograms per patch Norelgestromin: 6 milligrams per patch Administration Schedule: 1 patch applied every 7 days Total treatment duration: 21 days (3 patches total) Application Site: Upper torso (same as active treatment)
Drug: Transdermal Ethinyl Estradiol/Norelgestromin Patch
Placebo Transdermal Patch Detailed Description: Active Ingredients: None (placebo patch with identical appearance) Administration Schedule: 1 patch applied every 7 days Total treatment duration: 21 days (3 patches total) Application Site: Upper torso (same as active treatment)
Drug: Placebo Patch
Drug pages: Ethinyl Estradiol · Norelgestromin
Transdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott.
Also known as: Ethinyl Estradiol and Norelgestromin Transdermal Patch, Transdermal Contraceptive Patch, Combined Hormonal Contraceptive Patch, Hormonal Patch
Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14
The proportion of study participants who report complete cessation of abnormal vaginal bleeding while receiving the transdermal contraceptive patch treatment and continue to report no vaginal bleeding on day 14 of the 21-day treatment period.
Time frame: day 14 of treatment
Proportion of participants with at least 7 consecutive bleeding-free days during treatment month
Time frame: Throughout the treatment month (days 1-21 of treatment)
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 7
Time frame: day 7 of treatment
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21
Time frame: day 21 of treatment
Number of days of treatment required before cessation of vaginal bleeding
Time frame: From treatment initiation (day 1) until bleeding cessation, assessed throughout 21-day treatment period
Number of days of spotting/breakthrough bleeding during treatment
Time frame: Throughout the 21-day treatment period
Number of days before recurrence of vaginal bleeding after treatment cessation
Time frame: From end of treatment (day 21) until bleeding recurrence, assessed up to 3 months post-treatment
Treatment-related adverse events
Time frame: Throughout treatment period (21 days) and follow-up period (3 months post-treatment)
Treatment adherence/compliance
Time frame: Throughout the 21-day treatment period
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jul 2025 (actual). Primary completion is estimated for Sep 2026, 14 months after the start.
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Studies of the drugs tested here: Ethinyl Estradiol · Norelgestromin