Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users
NCT ID: NCT07083635
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2025-07-29
2026-12-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment
Transdermal Hormonal Contraceptive Patch (Ethinyl Estradiol and Norelgestromin)
Active Ingredients:
Ethinyl Estradiol: 600 micrograms per patch Norelgestromin: 6 milligrams per patch
Administration Schedule:
1 patch applied every 7 days Total treatment duration: 21 days (3 patches total) Application Site: Upper torso (same as active treatment)
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.
Placebo
Placebo Transdermal Patch
Detailed Description:
Active Ingredients: None (placebo patch with identical appearance)
Administration Schedule:
1 patch applied every 7 days Total treatment duration: 21 days (3 patches total) Application Site: Upper torso (same as active treatment)
Placebo Patch
Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.
Interventions
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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.
Placebo Patch
Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Tunchanok Juntamongkol, MD
Principal Investigator
Locations
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Family Planning Clinic, King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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107/68
Identifier Type: -
Identifier Source: org_study_id
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