Long Term Metformin in Women With Polycystic Ovary Syndrome

Completed

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT04043221
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

The investigators analyzed collection data of 10 years for the efficacy of metformin on body mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary syndrome (PCOS) and BMI ≥ 25kg/m2.

Each patient's age and height were recorded at baseline. In addition each patient weight, waist circumference, menstrual regularity, fasting glucose, glucose after 120 minute oral glucose tolerance test, luteinizing hormone, follicle stimulating hormone , free and direct testosterone, androstenedione, sex hormone binding globulin, dehydroepiandrosterone sulfate were identified at baseline and at the every follow up visit where available.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-01
• Primary Completion: 2008-12-01
• Study Completion: 2019-01-01
• Study First Submitted: 2019-07-09
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-01
• Last Update Submitted: 2019-08-01
• Study First Posted: 2019-08-02
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• PCOS phenotype A
• BMI≥ 25kg/m2
• metformin 1000mg twice a day for at least one year

Exclusion Criteria

• PCOS phenotype B, C, D
• BMI <25kg/m2
• had been treated with spironolactone or oral contraceptives alone or in combination with metformin
• had history of bariatric surgery
• became pregnant during the observation period
• had inability to tolerate metformin, leading to the cessation of drug therapy within first follow up year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
body weight	The measurement is assessed in kilograms at the beginning and after every year of taking metformin for 10 years.	Primary outcome was change in body weight.
menstrual frequency	The measurement is assessed in number of bleeds per year at the beginning and after every year of taking metformin for 10 years.	Primary outcome was change in menstrual frequency.
free testosterone	The measurement is assessed in nmol/L at the beginning and after every year of taking metformin for 10 years.	Primary outcome was change in levels of free testosterone.
diabetes mellitus	The measurement of glucose in blood is assessed in mmol/L at the beginning and after every year of taking metformin for 10 years.	Primary outcome was development of diabetes mellitus.

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia