Actively Recruiting

Phase 4
Age: 18Years - 45Years
FEMALE
NCT06543550

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

Led by Bio Meds Pharmaceutica Ltda · Updated on 2024-08-09

70

Participants Needed

4

Research Sites

61 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult female patients aged 18 to 45 years who are pre-menopausal and seeking treatment for endometriosis
  • Diagnosis of Grade 1 or 2 endometriosis confirmed by ultrasound or MRI with bowel preparation
  • Body mass index (BMI) of up to 25 kg/m2
  • Weight between 50 and 70 kg
  • Not currently receiving other therapies for endometriosis
Not Eligible

You will not qualify if you...

  • Pregnant patients (must provide supporting test)
  • Breastfeeding women
  • Using other hormonal contraceptives or copper/silver intrauterine devices
  • Patients with polycystic ovaries or hyperandrogenism
  • Using medications affecting androgen metabolism within 4 weeks before or during the study
  • History of liver disease, cardiovascular disease, active hepatitis, liver tumors, or kidney failure
  • Scheduled for surgical treatment during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Gm Ignacio Atividade Medica LTDA

Brasília, Federal District, Brazil, 70.390-150

Actively Recruiting

2

Instituto Longevite Servicos Medicos LTDA

Campina Grande, Paraíba, Brazil, 58.400-506

Actively Recruiting

3

Jpml Clinica Medica LTDA

São José dos Campos, São Paulo, Brazil, 12.246-876

Actively Recruiting

4

Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA

São Paulo, Brazil, 05.688-021

Actively Recruiting

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Research Team

A

André V. A. Florentino, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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