Optimizing metformin use in polycystic ovary syndrome - A randomized controlled trial

Phase 4

Not yet recruiting

Conditions: Polycystic ovary syndrome

Registration Number: 2023-509259-15-01

Lead Sponsor: HUS-yhtymae

Brief Summary: To find out if a metformin dose of 1500mg is inferior to 2250 mg per day regarding biochemical and clinical outcomes in overweight individuals 18-37 years of age with PCOS.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Female

Target Recruitment: 184

Inclusion Criteria

Women aged 18-37 years of age

A diagnosis of PCOS according to the updated 2023 International PCOS guideline

BMI ≥ 25 kg/m2 and <40 kg/m2

Signed informed consent and willingness to comply with the trial procedures

Exclusion Criteria

Females not meeting the 2003 Rotterdam criteria for PCOS

Investigator site staff directly involved in the conduct of the study and their family members

Females with hormonal contraceptive during the last 3 months

Women that are pregnant or breastfeeding

Females with an untreated diabetes, hypothyroidism or hyperprolactinemia

Use of medications for diabetes, high cholesterol, obesity and cortisone (per oral)

Serious mental illness

Females with contraindication for use of metformin (hypersensitivity to metformin, acute metabolic acidosis, severe renal failure, hepatic insufficiency, heart- or respiratory failure)

Alcoholism

A planned surgical intervention during the next 26 weeks

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anthropometrics (weight)		Anthropometrics (weight)
Androgenicity (hirsutism and testosterone)		Androgenicity (hirsutism and testosterone)
Metabolic (HOMA-IR)		Metabolic (HOMA-IR)
Gastrointestinal side-effects (nausea, vomiting, abdominal pain)		Gastrointestinal side-effects (nausea, vomiting, abdominal pain)
Polycystic ovary morphology: AMH		Polycystic ovary morphology: AMH

Secondary Outcome Measures

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

Trial Locations

Locations (1): Reproductive Medicine Unit, HUS
🇫🇮
Helsinki, Finland
Reproductive Medicine Unit, HUS
🇫🇮Helsinki, Finland
Johanna Maria Melin
Site contact
+358505382526
johanna.melin@hus.fi