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Идёт набор NCT07083635

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

Фаза II С лечением Menstruation Disturbances Metrorrhagia Uterine Hemorrhage Contraception Behavior

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transdermal Ethinyl Estradiol/Norelgestromin Patch, Placebo Patch.
Кому может быть актуально
Состояния в реестре: Menstruation Disturbances, Metrorrhagia, Uterine Hemorrhage, Contraception Behavior. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
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Официальное название

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

Обзор

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

Вмешательства

  • Препарат Transdermal Ethinyl Estradiol/Norelgestromin Patch
    Transdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott.
  • Препарат Placebo Patch
    Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.

Первичные конечные точки

  • Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14 [Срок оценки: day 14 of treatment]
Вторичные конечные точки (8)
  • Proportion of participants with at least 7 consecutive bleeding-free days during treatment month [Срок оценки: 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 [Срок оценки: day 7 of treatment]
  • Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21 [Срок оценки: day 21 of treatment]
  • Number of days of treatment required before cessation of vaginal bleeding [Срок оценки: From treatment initiation (day 1) until bleeding cessation, assessed throughout 21-day treatment period]
  • Number of days of spotting/breakthrough bleeding during treatment [Срок оценки: Throughout the 21-day treatment period]
  • Number of days before recurrence of vaginal bleeding after treatment cessation [Срок оценки: From end of treatment (day 21) until bleeding recurrence, assessed up to 3 months post-treatment]
  • Treatment-related adverse events [Срок оценки: Throughout treatment period (21 days) and follow-up period (3 months post-treatment)]
  • Treatment adherence/compliance [Срок оценки: Throughout the 21-day treatment period]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Таиланд · 1 центр
  • Family Planning Clinic, King Chulalongkorn Memorial Hospital — Pathum Wan

Идентификаторы

NCT: NCT07083635 · 107/68

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗