drugset / Trial / NCT01555190

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

NCT01555190

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-01
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Inositol Small molecule 1500 g
Comparator Inositol Small molecule 2000 g
Comparator folic acid Other / unclassified 200 ug