drugset / Trial / NCT07120815
Optimizing Metformin Use in Polycystic Ovary Syndrome
Phase 3
Not yet recruiting
184 enrolled
Helsinki University Central Hospital
Sakari Alhopuro foundation (funding) · collabThe Medical Society of Finland (funding) · collabValtion tutkimusraha (funding) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this clinical trial is to learn if a metformin dose of 1500 mg or 2250 mg per day is better to treat polycystic ovary syndrome (PCOS) in adults. It will also learn about the adverse effects of metformin. The trial aims to evaluate which metformin dose is better for: 1. improving biochemical and clinical outcomes 2. gastrointestinal side-effects 3. mental health and quality of life Participants will: * Be randomized to take metformin at a dose of either 1500mg or 2250mg every day for 6 months * Visit the clinic three times during the trial for checkups and tests * Answer questionnaires on menstrual cyclicity, mental health, quality of life and side-effects
Timeline
- Start
- 2025-09-01
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 1500 mg | — |
| Subject | Metformin | Small molecule | 2250 mg | — |