drugset / Trial / NCT01791647
Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Inositol | Small molecule | 1500 mg | — |
| Comparator | Metformin | Small molecule | 1500 mg | — |