drugset / Trial / NCT01791647

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

NCT01791647

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-06
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Inositol Small molecule 1500 mg
Comparator Metformin Small molecule 1500 mg