Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
NCT06543550
· ctgov
recruiting
phase phase-4
- Enrollment
- 70
- Start
- 2024-07-30
- Completion
- 2028-03-01
- Last updated
- 2026-10-20
- Has results
- False
- Countries
- Brazil
Conditions
Tagged with
Interventions
-
Implantable gestrinone
DRUG
1.6mg/kg of weight of gestrinone in pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region.
-
Oral Dienogest
DRUG
Administered orally at 2 mg daily
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 are scheduled for surgical treatment during the study period.
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine