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

Study Overview
=================
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.

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

Conditions
-----------------
Polycystic Ovary Syndrome, Hirsutism, Menstrual Irregularity

Intervention / Treatment
-----------------
* Drug: myo-inositol 1500 gr
* Drug: myo-inositol 2000 gr + folic acid 200 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: myo-inositol 1500 gr<br>6 months treatment with myo-inositol 1500 gr | Drug: myo-inositol 1500 gr<br> <br> |
| Active Comparator: myo-inositol 2000gr + folic acid 200 mcg<br> | Drug: myo-inositol 2000 gr + folic acid 200 mcg<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of cycles in six months of therapy | We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects on oral glucose tollerance test |  | six months | 
| effects on hoormonal assay |  | 6 months | 
| effects oon lipide profile |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myo-inositol, folic acid