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Идёт набор NCT06543550

Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis

Фаза IV С лечением Endometriosis

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: Implantable gestrinone, Oral Dienogest.
Кому может быть актуально
Состояния в реестре: Endometriosis. Базовые параметры: 18 лет — 45 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
Бразилия
Следующий шаг
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Официальное название

Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis: Randomized Controlled Clinical Trial

Обзор

This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.

Подробное описание

Patient recruitment will be carried out on a prospective basis and based on the group of patients from the private Medical Clinics in 4 cities (Campina Grande - Pb, São Paulo - SP, São José dos Campos - SP and Brasilia-DF). The study will include 70 adult female patients of menstrual age, pre-menopause (18 to 45 years old), who seek medical treatment to alleviate complaints related to endometriosis. The selected patients will be randomly allocated into two groups, in a 1:1 ratio. Control Group (n=35) - treatment with oral Dienogest - and Test Group (n=35) - Implantation of Gestrinone pellets. Follow-up visits will be scheduled after 1 week and 1, 3, 6, 9 and 12 months of initiation of therapy. Therapies will be compared with respect to the effects on the severity of dysmenorrhea, dyspareunia and non-cyclical pelvic pain (Verbal Scale and Visual Analogue Scale), level of Uterine Bleeding assessed by PBAC, systemic effects (hormonal, hepatic, lipid profile, cell concentration red, clotting factor - assessed through blood tests), endometriosis lesions, endometrial thickness (transvaginal ultrasound), body composition (bioimpendance test), quality of life (EHP30) and sexual function (female sexual function index ) - FSFI. Data analysis will be carried out using validated statistical software. Chi-square or Fisher\'s exact tests will be used to compare qualitative variables, while independent t-tests will be used to compare quantitative variables between the two groups. Analysis of variance with repeated measures will be used to compare the average pain intensity over time. The significance level for all tests will be p\<0.05.

Вмешательства

  • Препарат Implantable gestrinone
    1.6mg/kg of weight of gestrinone in pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region.
  • Препарат Oral Dienogest
    Administered orally at 2 mg daily

Первичные конечные точки

  • Evaluation of dysmenorrhea severity [Срок оценки: Pre-treatment, 1 week, 1, 3 , 6 and 12 months]
  • Evaluation of dyspareunia severity [Срок оценки: Pre-treatment, 1 week, 1, 3 , 6 and 12 months]
  • Evaluation of non-cyclical pelvic pain severity [Срок оценки: Pre-treatment, 1 week, 1, 3 , 6 and 12 months]
  • Evaluation of endometriosis foci regression [Срок оценки: Pre-treatment, 6 and 12 months]
Вторичные конечные точки (5)
  • Evaluation of quality of life [Срок оценки: Pre-treatment, 6 and 12 months]
  • Evaluation of adverse effect [Срок оценки: Pre-treatment, 1 week, 1, 3 , 6 and 12 months]
  • Evaluation of abnormal Uterine Bleeding (AUB) [Срок оценки: Pre-treatment, 1, 3 , 6 and 12 months]
  • Evaluation of sexual function [Срок оценки: Pre-treatment, 1 week, 1, 3 , 6 and 12 months]
  • Evaluation of body composition [Срок оценки: Pre-treatment, 3 , 6 and 12 months]

Критерии участия

Критерии включения

  • Adult female patients of menstrual age, pre-menopause (18 to 45 years old), who seek medical treatment to alleviate complaints related to endometriosis, who are not undergoing other therapies to treat them.
  • Patients must have a diagnosis of Grade 1 or 2 endometriosis assessed by imaging tests (ultrasound with bowel preparation and/or MRI of the pelvis with bowel preparation)14, have a BMI of up to 25kg/m2, and weigh between 50 and 70kg.

Критерии исключения

  • Pregnant patients (supporting test must be presented)
  • Breastfeeding women, using other hormonal contraceptive methods or copper or silver IUDs, who have polycystic ovaries, and/or hyperandrogenism.
  • Patients using medications that may interfere with androgen metabolism within 4 weeks of screening or during the study.
  • Patients with a history of liver disease, cardiovascular disease (myocardial infarction, unstable angina or heart failure), active hepatitis, liver neoplasia or renal failure
  • Patient who are scheduled for surgical treatment during the study period.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Бразилия · 4 центра
  • Gm Ignacio Atividade Medica LTDA — Brasília
  • Instituto Longevite Servicos Medicos LTDA — Campina Grande
  • Jpml Clinica Medica LTDA — São José dos Campos
  • Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA — São Paulo

Идентификаторы

NCT: NCT06543550 · CS.001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗