L26/P-720 Optimizing metformin use in polycystic ovary syndrome (MET-PCOS) - Study protocol for a double-blind randomized controlled trial
Abstract
Is a metformin dose of 1500 mg daily inferior to 2250 mg in improving biochemical and clinical outcomes in polycystic ovary syndrome (PCOS).
This double-blind randomised controlled trial (RCT) aims to identify the optimal metformin dose for PCOS and assist physicians in treating individuals with PCOS.
PCOS is one of the most prevalent endocrine disorders globally, affecting 11-13 % of women during reproductive age. PCOS is associated with an elevated risk of reproductive, metabolic, endocrine, and mental health challenges. The international PCOS guideline 2023 recommends lifestyle changes as first-line treatment for managing PCOS. In addition, metformin should be considered in individuals with a BMI ≥ 25 kg/m². Unfortunately, adverse gastrointestinal effects are common in metformin users and may lead to discontinuation of the treatment. The optimal metformin dose for individuals with PCOS is unclear, as there are very few studies comparing different metformin doses in PCOS.
MET-PCOS is a double-blind RCT conducted at Helsinki University Hospital among individuals with PCOS. A total of 184 participants will be randomized (1:1) to receive a metformin dose of 1500 mg or 2250 mg per day. Study outcomes will be assessed at baseline and at 14 and 26 weeks using clinical measurements, laboratory tests, and questionnaires. Recruitment of participants began in November 2025, and the trial is expected to end by December 2027.
We will include participants aged 18-37 years with a BMI ≥…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 184 participants or records.
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