Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial

Early Phase 1

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Placebo; Drug: Inositol

• Registration Number: NCT01574261
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

Polycystic ovary syndrome (PCOS) is associated with an increased cardiovascular risk. The aim of the study was to evaluate long-term effects of inositol on some cardiovascular risk factors in PCOS patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-09
• Last Update Submitted: 2012-04-09
• Study First Posted: 2012-04-10
• Last Update Posted: 2012-04-10
• Primary Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Polycystic Ovary Syndrome
• Age >18 and <35

Exclusion Criteria

• Chronic or acute inflammatory disease, cancer, autoimmune disease, treatment during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will be randomized to receive placebo for four months
Inositol	Inositol	Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment

Primary Outcome Measures

Name	Time	Method
CD4+ CD28 null T-lymphocyte frequency	five minutes

Secondary Outcome Measures

Name	Time	Method
insulinaemic area OGTT AUCi, lipid profile, androgen levels	120 minutes

Trial Locations

Locations (1)

Università cattolica S. Cuore; 🇮🇹 Rome, Italy