Comparing Implantable Gestrinone and Oral Dienogest for Endometriosis Treatment
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis: Randomized Controlled Clinical Trial
This study is testing whether an implantable form of Gestrinone works better than the oral medication Dienogest for relieving endometriosis symptoms in women aged 18 to 45.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Bio Meds Pharmaceutica Ltda Industry-sponsored |
| Locations | 4 sites (Brasília, Federal District and 3 other locations) |
| Trial ID | NCT06543550 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 to 45 with a diagnosis of Grade 1 or 2 endometriosis seeking treatment.
Not a fit: Patients who are pregnant, breastfeeding, or have certain hormonal or medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women suffering from endometriosis.
How similar studies have performed: Other studies have shown promise in using hormonal treatments for endometriosis, but the specific comparison of implantable Gestrinone to oral Dienogest is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brasília, Federal District and 3 other locations
- Gm Ignacio Atividade Medica LTDA — Brasília, Federal District, Brazil (Recruiting)
- Instituto Longevite Servicos Medicos LTDA — Campina Grande, Paraíba, Brazil (Recruiting)
- Jpml Clinica Medica LTDA — São José dos Campos, São Paulo, Brazil (Recruiting)
- Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: André V. A. Florentino, Dr
- Email: f.andrevinicius@gmail.com
- Phone: +55 83 982001868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.