Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Metformin in Women With Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 9, 2019
First Posted Date August 2, 2019
Last Update Posted Date August 2, 2019
Actual Study Start Date January 1, 2006
Actual Primary Completion Date December 1, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 1, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Metformin in Women With Polycystic Ovary Syndrome
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Polycystic Ovary Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 1, 2019)
180
Original Actual Enrollment Same as current
Actual Study Completion Date January 1, 2019
Actual Primary Completion Date December 1, 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04043221
Other Study ID Numbers MET retro
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Andrej Janez, University Medical Centre Ljubljana
Study Sponsor University Medical Centre Ljubljana
Collaborators Not Provided
Investigators Not Provided
PRS Account University Medical Centre Ljubljana
Verification Date August 2019