Comparing Implantable Gestrinone and Oral Dienogest for Endometriosis Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of implantable Gestrinone versus oral Dienogest in alleviating symptoms of endometriosis in adult women. A total of 70 pre-menopausal women aged 18 to 45 will be recruited from private medical clinics across four cities in Brazil. Participants will be randomly assigned to receive either the implantable treatment or the oral medication, with follow-up assessments scheduled at various intervals to monitor pain severity, bleeding levels, and overall quality of life. Data will be analyzed using validated statistical methods to determine the comparative efficacy of the two treatments.

Why it matters

Who can join: the full rules

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's running

• Instituto Longevite Servicos Medicos LTDA
  Campina Grande, Paraíba, Brazil Recruiting
• Nutrindo Ideiais Rio de Janeiro
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
• Jpml Clinica Medica LTDA
  São José dos Campos, São Paulo, Brazil Recruiting
• Nutrindo Ideiais São Paulo
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: André V. A. Florentino, Dr
• Email: f.andrevinicius@gmail.com
• Phone: +55 83 982001868

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.