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

Catholic University of the Sacred Heart

Status

Completed

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: metformin 1500 mg

Drug: myoinositol 1500 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT01791647

000102011

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.