Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
Recruiting · NCT06543550 · Interventional (participants receive a specific treatment) · Lead sponsor: Bio Meds Pharmaceutica Ltda
View the official record on ClinicalTrials.gov →Interventions studied
Implantable gestrinoneOral Dienogest
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.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 are scheduled for surgical treatment during the study period.
Where it is running
4 locations listed.
- Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA - São Paulo, Brazil
- Gm Ignacio Atividade Medica LTDA - Brasília, Federal District, Brazil
- Instituto Longevite Servicos Medicos LTDA - Campina Grande, Paraíba, Brazil
- Jpml Clinica Medica LTDA - São José dos Campos, São Paulo, Brazil