Long Term Metformin in Women With Polycystic Ovary Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

body weight

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Effects of Long Term Treatment With Metformin on Clinical, Metabolic and Endocrine Parameters in Women With Polycystic Ovary Syndrome And Increased Metabolic Risk

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2019
First posted: Aug 2, 2019
Registry last updated: Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed