metformin for Polycystic ovary syndrome

Inclusion criteria

• {"criterion_text":"- Women aged 18-37 years of age\n- A diagnosis of PCOS according to the updated 2023 International PCOS guideline\n- BMI ≥ 25 kg/m2 and <40 kg/m2\n- Signed informed consent and willingness to comply with the trial procedures"}

Exclusion criteria

• {"criterion_text":"- Females not meeting the 2003 Rotterdam criteria for PCOS\n- Investigator site staff directly involved in the conduct of the study and their family members\n- Females with hormonal contraceptive during the last 3 months\n- Women that are pregnant or breastfeeding\n- Females with an untreated diabetes, hypothyroidism or hyperprolactinemia\n- Use of medications for diabetes, high cholesterol, obesity and cortisone (per oral)\n- Serious mental illness\n- Females with contraindication for use of metformin (hypersensitivity to metformin, acute metabolic acidosis, severe renal failure, hepatic insufficiency, heart- or respiratory failure)\n- Alcoholism\n- A planned surgical intervention during the next 26 weeks"}

Primary endpoints

• {"endpoint_text":"- Anthropometrics (weight)\n- Androgenicity (hirsutism and testosterone)\n- Metabolic (HOMA-IR)\n- Gastrointestinal side-effects (nausea, vomiting, abdominal pain)\n- Polycystic ovary morphology: AMH","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Androgenicity: FAI, SHBG, DHEAS, androstenedione, free testosterone, acne and alopecia\n- Menstrual cyclicity (questionnaire where asking how long the two previous cycles were (days)\n- Quality of life and weight stigma: anxiety, weight stigma\n- Metabolic: fasting glucose, fasting insulin, HbA1C, lipids, CRP, ALAT, GGT, OGTT, FLI, Matsuda Index, TyG index\n- Polycystic ovary morphology: ultrasound (follicle number per ovary, ovarian volume)\n- Anthropometric (BMI, waist-hip-ratio, WC, BAI, body composition, bloodpressure, pulse)","definition_or_measurement_approach":""}

Finland

Earliest CTIS Part Ii Submission Date

11-01-2025

Latest Decision Or Authorization Date

09-02-2025

Processing Time Days

29

Number Of Sites

1

Number Of Participants

184

Primary sponsor

Full Name

HUS-yhtymae

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland

Third parties

• {"country":"","full_name":"Finska Läkaresällskapet","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Valtion tutkimusraha (VTR)","duties_or_roles":"Source of monetary support","organisation_type":""}