Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone

Catholic University of the Sacred Heart

Status

Completed

Conditions

Menstrual Irregularity

Polycystic Ovary Syndrome

Hirsutism

Treatments

Drug: myo-inositol 1500 gr

Drug: myo-inositol 2000 gr + folic acid 200 mcg

Study type

Interventional

Funder types

Other

Identifiers

NCT01555190

000102012

Details and patient eligibility

About

Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.

Enrollment

50 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

women with PCOS 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 dysfunctions (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 entering the study.