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Long Term Metformin in Women With Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT04043221
Recruitment Status : Completed
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Andrej Janez, University Medical Centre Ljubljana

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.


Condition or disease
Polycystic Ovary Syndrome

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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Other
Time Perspective: Retrospective
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
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : December 1, 2008
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043221


Locations
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Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana

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Responsible Party: Andrej Janez, Clinical professor, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT04043221     History of Changes
Other Study ID Numbers: MET retro
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs