Status:
RECRUITING
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
Lead Sponsor:
Bio Meds Pharmaceutica Ltda
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.
Detailed Description
Patient recruitment will be carried out on a prospective basis and based on the group of patients from the private Medical Clinics in 4 cities (Campina Grande - Pb, São Paulo - SP, São José dos Campos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06543550
Start Date
July 30 2024
End Date
October 1 2025
Last Update
August 9 2024
Active Locations (4)
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1
Gm Ignacio Atividade Medica LTDA
Brasília, Federal District, Brazil, 70.390-150
2
Instituto Longevite Servicos Medicos LTDA
Campina Grande, Paraíba, Brazil, 58.400-506
3
Jpml Clinica Medica LTDA
São José dos Campos, São Paulo, Brazil, 12.246-876
4
Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA
São Paulo, Brazil, 05.688-021