Long Term Metformin in Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043221
• Other study ID #: MET retro
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: January 1, 2019

Study information

• Verified date: August 2019
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 1, 2019
• Est. primary completion date: December 1, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.