RecruitingPhase 4NCT06543550
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis: Randomized Controlled Clinical Trial
Sponsor
Bio Meds Pharmaceutica Ltda
Enrollment
70 participants
Start Date
Jul 30, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years
Inclusion Criteria2
- 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 Criteria5
- 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.
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Interventions
DRUGImplantable gestrinone
1.6mg/kg of weight of gestrinone in pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region.
DRUGOral Dienogest
Administered orally at 2 mg daily
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06543550
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