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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Inositol; Metformin

Criteria

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.