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Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Maurizio Guido, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01791647
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
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.
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart
March 12, 2012
February 15, 2013
February 15, 2013
June 2011
December 2012   (Final data collection date for primary outcome measure)
number of cycles [ Time Frame: six months ]
Same as current
No Changes Posted
effects of two therapies on glyco-insulinemic metabolism [ Time Frame: six months ]
Area under the curve insulin post oral glucose tolerance test (μUI/ML/180min), M value of euglycemic hyperinsulinaemic clamp(mg/kg/min).
Same as current
Not Provided
Not Provided
 
Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome
Myo-inositol Versus Metformin: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome
The aim of this study is to compare the effects of six months treatment of two insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women affected by polycystic ovary syndrome. The study group includes 40 patients, randomly allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day). The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline and after six months of treatment.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Drug: metformin 1500 mg
  • Drug: myoinositol 1500 mg
  • Active Comparator: myo-inositol
    1500 mg/day myoinositol
    Intervention: Drug: myoinositol 1500 mg
  • Active Comparator: metformin
    1500 mg/day of metformin
    Intervention: Drug: metformin 1500 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Not Provided
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • women with Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003;
  • BMI>25 kg/m2;
  • age 18-35 years.

Exclusion Criteria:

  • pregnancy;
  • significant liver or renal impairment;
  • other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs);
  • neoplasms;
  • unstable mental illness;
  • diagnosis of diabetes mellitus or impaired glucose tolerance;
  • use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study.
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01791647
000102011
Not Provided
Not Provided
Not Provided
Maurizio Guido, Catholic University of the Sacred Heart
Catholic University of the Sacred Heart
Not Provided
Not Provided
Catholic University of the Sacred Heart
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP