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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04043221

Enrollment

180

Registered

2019-08-02

Start date

2006-01-01

Completion date

2019-01-01

Last updated

2019-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Slovenia

Outcome results