Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
Recruiting now · Phase 4
Conditions studied: Endometriosis
In brief
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.
Key facts
- Study ID
- NCT06543550
- Run by
- Bio Meds Pharmaceutica Ltda
- People needed
- 70
- Starts
- 2024-07-30
- Expected to finish
- 2025-10-01
- Last updated by the study team
- 2024-08-09
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Gm Ignacio Atividade Medica LTDA — Brasília, Federal District, Brazil (enrolling)
- Instituto Longevite Servicos Medicos LTDA — Campina Grande, Paraíba, Brazil (enrolling)
- Jpml Clinica Medica LTDA — São José dos Campos, São Paulo, Brazil (enrolling)
- Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA — São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
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