Clinical trial · Interventional
Optimizing Metformin Use in Polycystic Ovary Syndrome
Optimizing Metformin Use in Polycystic Ovary Syndrome - A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Women 18-37 years old with a BMI ≥ 25 kg/m2, metformin 2250mg per day
- description
- metformin tablets 2250 mg per day
- interventionNames
- Drug: Metformin 2250 mg daily
- type
- EXPERIMENTAL
- label
- Women 18-37 years old with a BMI ≥ 25 kg/m2, metformin 1500mg per day
- description
- metformin tablets 1500 mg per day
- interventionNames
- Drug: Metformin 1500 mg daily
Primary outcomes (6)
- measure
- Weight
- timeFrame
- The investigators will measure change in outcomes from baseline to 14 and 26 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 37 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed PCOS (According to the International evidence-based Guideline for PCOS 2023) * Age: 18-37 years * BMI: ≥ 25 and \<40 kg/m2 * Signed informed consent and willingness to comply with the trial procedures * Sufficient skills in the Finnish or Swedish language Exclusion Criteria: * Not meeting the criteria according to the International evidence-based Guideline for PCOS 2023) * Use of hormonal contraceptive during the last 3 months * Pregnancy * Breastfeeding * Untreated diabetes * Hypothyroidism * Hyperprolactinemia * Use of medications for diabetes, * Use of medications for high cholesterol * Use of medications for obesity * Use of medications for cortisone (per oral) * Hypersensitivity to metformin * Acute metabolic acidosis * Renal impairment * Hepatic insufficiency * Heart- or respiratory failure * Serious mental illness * Alcoholism * Investigator site staff directly involved in the conduct of the study and their family members
References
Publications (1)
- DERIVEDHautamaki HM, Savolainen-Peltonen H, Rono K, Melin J. Optimising metformin use in polycystic ovary syndrome (MET-PCOS): study protocol for a double-blind randomised controlled trial. BMJ Open. 2026 Mar 12;16(3):e115656. doi: 10.1136/bmjopen-2025-115656. PMID 41819580