Family Planning Clinic, King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10400, Thailand
Location status: Recruiting
NCT Number: NCT07083635
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
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 2
Pathum Wan, Bangkok, 10400, Thailand
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott.
Other names: 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.
Time frame: day 14 of treatment
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: Throughout the treatment month (days 1-21 of treatment)
Time frame: day 7 of treatment
Time frame: day 21 of treatment
Time frame: From treatment initiation (day 1) until bleeding cessation, assessed throughout 21-day treatment period
Time frame: Throughout the 21-day treatment period
Time frame: From end of treatment (day 21) until bleeding recurrence, assessed up to 3 months post-treatment
Time frame: Throughout treatment period (21 days) and follow-up period (3 months post-treatment)
Time frame: Throughout the 21-day treatment period
Contact information is provided by the study sponsor or research team.
Chulalongkorn University
Other
Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users: A Randomized, Double-Blind, Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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