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

Phase

Condition

Endometriosis

Treatment

Implantable gestrinone

Oral Dienogest

Clinical Study ID

NCT06543550

CS.001

Ages 18-45
Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adult female patients of menstrual age, pre-menopause (18 to 45 years old), who seekmedical treatment to alleviate complaints related to endometriosis, who are notundergoing other therapies to treat them.
Patients must have a diagnosis of Grade 1 or 2 endometriosis assessed by imagingtests (ultrasound with bowel preparation and/or MRI of the pelvis with bowelpreparation)14, have a BMI of up to 25kg/m2, and weigh between 50 and 70kg.

Exclusion

Exclusion Criteria:

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

Study Design

Implantable gestrinone

July 30, 2024

October 31, 2025

Study Description

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&#39;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.

Connect with a study center

Gm Ignacio Atividade Medica LTDA
Brasília, Distrito Federal 70.390-150
Brazil
Active - Recruiting
Instituto Longevite Servicos Medicos LTDA
Campina Grande, Paraíba 58.400-506
Brazil
Active - Recruiting
Jpml Clinica Medica LTDA
São José dos Campos, São Paulo 12.246-876
Brazil
Active - Recruiting
Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA
São Paulo, 05.688-021
Brazil
Active - Recruiting

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