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NCT Number: NCT07083635

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Family Planning Clinic, King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10400, Thailand

Location status: Recruiting

Location contact

Tunchanok Juntamongkol, Doctor of Medicine

CONTACT

[email protected]

+66818084336

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdermal Ethinyl Estradiol/Norelgestromin Patch

Drug

Transdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott.

Other names: Ethinyl Estradiol and Norelgestromin Transdermal Patch, Transdermal Contraceptive Patch, Combined Hormonal Contraceptive Patch, Hormonal Patch

Placebo Patch

Drug

Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Proportion of participants with at least 7 consecutive bleeding-free days during treatment month

    Time frame: Throughout the treatment month (days 1-21 of treatment)

  2. Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 7

    Time frame: day 7 of treatment

  3. Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21

    Time frame: day 21 of treatment

  4. Number of days of treatment required before cessation of vaginal bleeding

    Time frame: From treatment initiation (day 1) until bleeding cessation, assessed throughout 21-day treatment period

  5. Number of days of spotting/breakthrough bleeding during treatment

    Time frame: Throughout the 21-day treatment period

  6. Number of days before recurrence of vaginal bleeding after treatment cessation

    Time frame: From end of treatment (day 21) until bleeding recurrence, assessed up to 3 months post-treatment

  7. Treatment-related adverse events

    Time frame: Throughout treatment period (21 days) and follow-up period (3 months post-treatment)

  8. Treatment adherence/compliance

    Time frame: Throughout the 21-day treatment period

Study contacts

Contact information is provided by the study sponsor or research team.

Tunchanok Juntamongkol, M.D.

CONTACT

[email protected]

+6626494000

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users: A Randomized, Double-Blind, Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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