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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Transdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott.
Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.
Family Planning Clinic, King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand
RECRUITINGProportion 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
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