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

Not Applicable

Not yet recruiting

• Conditions: Menstruation Disturbances; Contraception Behavior; Metrorrhagia; Uterine Hemorrhage
• Interventions: Drug: Transdermal Ethinyl Estradiol/Norelgestromin Patch; Drug: Placebo Patch

• Registration Number: NCT07083635
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2025-09-01
• Primary Completion: 2025-09
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Transdermal Ethinyl Estradiol/Norelgestromin Patch	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)
Placebo	Placebo Patch	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)

Primary Outcome Measures

Name	Time	Method
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14	day 14 of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Treatment-related adverse events	Throughout treatment period (21 days) and follow-up period (3 months post-treatment)
Treatment adherence/compliance	Throughout the 21-day treatment period
Proportion of participants with at least 7 consecutive bleeding-free days during treatment month	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	day 7 of treatment
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21	day 21 of treatment
Number of days of treatment required before cessation of vaginal bleeding	From treatment initiation (day 1) until bleeding cessation, assessed throughout 21-day treatment period
Number of days of spotting/breakthrough bleeding during treatment	Throughout the 21-day treatment period
Number of days before recurrence of vaginal bleeding after treatment cessation	From end of treatment (day 21) until bleeding recurrence, assessed up to 3 months post-treatment