Long Term Metformin in Women With Polycystic Ovary Syndrome

NCT ID: NCT04043221

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-01

Study Completion Date

2019-01-01

Brief Summary

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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

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Andrej Janez

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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MET retro

Identifier Type: -

Identifier Source: org_study_id

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