NCT06543550 Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
| NCT ID | NCT06543550 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Bio Meds Pharmaceutica Ltda |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-07-30 |
| Primary Completion | 2025-09 |
Trial Parameters
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Brief 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 Criteria: * 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. Exclusion Criteria: * 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