Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users: A Randomized, Double-Blind, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment
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)
干预措施: Transdermal Ethinyl Estradiol/Norelgestromin Patch (Drug)
Placebo
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)
干预措施: Placebo Patch (Drug)
结局指标
主要结局
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14
时间窗: 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.
次要结局
- 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)
研究者
Tunchanok Juntamongkol, MD
Principal Investigator
Chulalongkorn University