NCT07120815Not yet recruitingPhase 3
Optimizing Metformin Use in Polycystic Ovary Syndrome
Optimizing Metformin Use in Polycystic Ovary Syndrome - A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 184 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Helsinki University Central Hospital
- NCT number
- NCT07120815
- EU CT number
- 2023-509259-15-01
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 184
- From 1 Sept 2025 to the primary completion date, 31 Dec 2027
- 1 site 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
- Use of medications for high cholesterol
- Use of medications for obesity
- Use of medications for cortisone (per oral)
Other illness
- Untreated diabetes
- Use of medications for diabetes,
- Hypersensitivity to metformin
- Renal impairment
- Hepatic insufficiency
- Heart- or respiratory failure
- Serious mental illness
Other
- 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
- Hypothyroidism
- Hyperprolactinemia
- Acute metabolic acidosis
- Alcoholism
- Investigator site staff directly involved in the conduct of the study and their family members
Who the study is looking for
- 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
Age in the registry: 18 years to 37 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Reproductive Medicine Unit, Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.