Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
NCT ID: NCT06543550
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
70 participants
INTERVENTIONAL
2024-07-30
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Implantable Gestrinone
Implantation of Gestrinone pellets - Eligible patients will undergo implantation of Gestrinone pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region, using aseptic technique under local anesthesia. Patients will use 1.6mg/kg of weight to treat endometriosis. A second implantation procedure will be performed 6 months after the first, allowing evaluation of the effects of the therapy over a period of 12 months.
Implantable gestrinone
1.6mg/kg of weight of gestrinone in pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region.
Oral Dienogest
Patients will receive the medication to be administered orally at 2mg daily for 12 months.
Oral Dienogest
Administered orally at 2 mg daily
Interventions
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Implantable gestrinone
1.6mg/kg of weight of gestrinone in pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region.
Oral Dienogest
Administered orally at 2 mg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Bio Meds Pharmaceutica Ltda
INDUSTRY
Responsible Party
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Locations
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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
Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CS.001
Identifier Type: -
Identifier Source: org_study_id
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