Long Term Metformin in Women With Polycystic Ovary Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Center Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Collection data from endocrine outpatient clinic for 10 years of women with PCOS phenotype A, BMI≥ 25kg/m2, all receiving monotherapy with metformin 1000 mg twice a day.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	Primary outcome was change in body weight.	The measurement is assessed in kilograms at the beginning and after every year of taking metformin for 10 years.
menstrual frequency	Primary outcome was change in 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.
free testosterone	Primary outcome was change in levels of free testosterone.	The measurement is assessed in nmol/L at the beginning and after every year of taking metformin for 10 years.
diabetes mellitus	Primary outcome was development of 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.

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: MET retro

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No