Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transdermal Ethinyl Estradiol/Norelgestromin Patch, Placebo Patch.
- Who it may be relevant to
- Registry conditions: Menstruation Disturbances, Metrorrhagia, Uterine Hemorrhage, Contraception Behavior. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users: A Randomized, Double-Blind, Controlled Trial
Overview
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
Interventions
- Drug Transdermal Ethinyl Estradiol/Norelgestromin Patch
Transdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott. - Drug Placebo Patch
Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.
Primary outcome measures
- Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14 [Time frame: day 14 of treatment]
Secondary outcome measures (8)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Family Planning Clinic, King Chulalongkorn Memorial Hospital — Pathum Wan
Identifiers
NCT: NCT07083635 · 107/68