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PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Implantable gestrinone for Endometriosis

This study aims to measure the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.

Official registry: https://clinicaltrials.gov/study/NCT06543550 · Bio Meds Pharmaceutica Ltda · enrollment listed as 70

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Implantable gestrinone, or Oral Dienogest. The registry lists allocation as randomized. This study aims to measure the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.

They plan to enroll about 70 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis: Randomized Controlled Clinical Trial

Interventions: Implantable gestrinone, Oral Dienogest

Primary outcome (registry wording): Evaluation of dysmenorrhea severity

Who it is for (from inclusion criteria)

  • Ages 18 Years to 45 Years
  • Women only
  • 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 body-mass index (BMI) of up to 25kg/m2, and weigh between 50 and 70kg

Public study contact (from the registry)

André V. A. Florentino, Dr

+55 83 982001868

f.andrevinicius@gmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

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NCT04567771 · Official ClinicalTrials.gov record · Mayo Clinic

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Not a traditional drug phase: Observational study, no intervention for Endometriosis

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FAQ about this NCT record

Is NCT06543550 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06543550?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06543550?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary