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Compares two metformin doses for polycystic ovary syndrome in adults

Tests which metformin dose treats polycystic ovary syndrome in adults.

Plain-language title generated from the registry record
Registry title: Optimizing Metformin Use in Polycystic Ovary Syndrome

Key facts

Where
Helsinki, FinlandSee the site
Phase
Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 37 years old?

Source: NCT07120815, who can take part

Where in Finland

  • Reproductive Medicine Unit, HUSHelsinki, FinlandNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Helsinki University Central Hospital
Trial code
NCT07120815EU 2023-509259-15-01
Record updated
13 August 2025
Original description
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:Read full original descriptionShow less

Optimizing Metformin Use in Polycystic Ovary Syndrome - A Randomized Controlled Trial

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

Inclusion: 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: Use of medications for high cholesterol; Use of medications for obesity; Use of medications for cortisone (per oral); Untreated diabetes; Use of medications for diabetes,; Hypersensitivity to metformin; Renal impairment; Hepatic insufficiency; Heart- or respiratory failure; Serious mental illness; 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.

ClinicalTrials.gov NCT07120815 · EU CTIS 2023-509259-15-01