NCT06543550RecruitingPhase 4
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis: Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 31 Jul 2024
- Start date
- 30 Jul 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Bio Meds Pharmaceutica Ltda
- Diseases
- Endometriosis
- NCT number
- NCT06543550
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 70
- From 30 Jul 2024 to the primary completion date, 31 Mar 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients using medications that may interfere with androgen metabolism within 4 weeks of screening or during the study.
- Patient who are scheduled for surgical treatment during the study period.
Other illness
- Patients with a history of liver disease, cardiovascular disease (myocardial infarction, unstable angina or heart failure), active hepatitis, liver neoplasia or renal failure
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Longevite Servicos Medicos LTDA Coordinator of this site? Confirm its status | Campina Grande | Brazil | Recruiting |
| Nutrindo Ideiais Rio de Janeiro Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Jpml Clinica Medica LTDA Coordinator of this site? Confirm its status | São José dos Campos | Brazil | Recruiting |
| Nutrindo Ideiais São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.