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Optimising metformin use in polycystic ovary syndrome (MET-PCOS): study protocol for a double-blind randomised controlled trial - PubMed

7 hours ago
  • #PCOS
  • #Metformin
  • #Randomized Controlled Trial
  • The MET-PCOS trial aims to optimize metformin use in PCOS by comparing doses of 1500 mg/day and 2250 mg/day.
  • PCOS affects 11-13% of women of reproductive age and is linked to reproductive, metabolic, endocrine, and mental health issues.
  • Lifestyle changes are first-line treatment, but metformin is recommended for those with BMI ≥25 kg/m².
  • The study is a double-blind randomized controlled trial with 184 participants aged 18-37, meeting Rotterdam criteria for PCOS.
  • Outcomes include metabolic markers, hyperandrogenism, ovarian morphology, menstrual cyclicity, mental health, and gastrointestinal effects.
  • Measurements will be taken at baseline, 14 weeks, and 26 weeks.
  • The trial is approved by Finnish regulatory bodies and aims to guide optimal metformin dosing in PCOS.
  • Trial registration numbers: NCT07120815 and EU 2023-509259-15-01.