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Spots Global Cancer Trial Database for Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone

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Trial Identification

Brief Title: Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone

Official Title: Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome

Study ID: NCT01555190

Study Description

Brief Summary: 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Catholic University of Sacred Heart, Rome, , Italy

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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