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

Chulalongkorn University

Status and phase: Enrolling; Phase 2

Conditions: Metrorrhagia; Menstruation Disturbances; Contraception Behavior; Uterine Hemorrhage

Treatments: Drug: Placebo Patch; Drug: Transdermal Ethinyl Estradiol/Norelgestromin Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT07083635

107/68

Details and patient eligibility

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

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

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)

Treatment:

Drug: Transdermal Ethinyl Estradiol/Norelgestromin Patch

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo Patch