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

NCT07083635 | Recruiting Phase 2

• 1 other identifier: 107/68
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Menstruation Disturbances; Metrorrhagia; Uterine Hemorrhage; Contraception Behavior

Keywords

Contraceptive implant; Abnormal vaginal bleeding; Bothersome vaginal bleeding; Irregular vaginal bleeding; Transdermal hormonal contraception; Ethinyl estradiol; Norelgestromin; Abnormal uterine bleeding; Contraceptive-induced bleeding; Combined hormonal contraception; Hormonal contraceptive patch

Outcome Measures

Primary Outcomes (1)

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

  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.

  day 14 of treatment

Secondary Outcomes (8)

• 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

Study Arms (2)

Treatment

EXPERIMENTAL

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)

Drug: Transdermal Ethinyl Estradiol/Norelgestromin Patch

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo Patch

Interventions

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.

Also known as: Ethinyl Estradiol and Norelgestromin Transdermal Patch, Transdermal Contraceptive Patch, Combined Hormonal Contraceptive Patch, Hormonal Patch

Treatment

Placebo Patch DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Family Planning Clinic, King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Menstruation Disturbances; Metrorrhagia; Uterine Hemorrhage; Contraception Behavior

Interventions

Ethinyl Estradiol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Reproductive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Tunchanok Juntamongkol, M.D.

CONTACT

+6626494000; tunchanok.junt@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 24, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)