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Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users

RecruitingPhase 2Ages 18 Years - anyFemaleChulalongkorn University
NCT07083635 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 va

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📋 Eligibility rules (as published)
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
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What it tests

  • Transdermal Ethinyl Estradiol/Norelgestromin Patch
  • Placebo Patch
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Where

1 site
Family Planning Clinic, King Chulalongkorn Memorial Hospital
Pathum Wan, Thailand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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