Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT07083635

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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