Trial Information
Myo-inositol Versus Metformin: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
number of cycles
Outcome Time Frame:
six months
Safety Issue:
No
Authority:
Italy: Catholic University of Sacred Heart
Study ID:
000102011
NCT ID:
NCT01791647
Start Date:
June 2011
Completion Date:
Related Keywords:
- Polycystic Ovary Syndrome
- Polycystic ovary syndrome
- myoinositol
- metformin
- glucose-insulinemic metabolism
- menstrual pattern
- insulin-lowering therapies
- Polycystic Ovary Syndrome