Actively Recruiting
Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users
Led by Chulalongkorn University · Updated on 2025-12-10
40
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years and older
- Regular menstrual cycles with at least 1 cycle before 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 lasting more than 8 consecutive days or bleeding-free intervals of 15 days or less
You will not qualify if you...
- 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, or dizziness
AI-Screening
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Trial Site Locations
Total: 1 location
1
Family Planning Clinic, King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand, 10400
Actively Recruiting
Research Team
T
Tunchanok Juntamongkol, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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