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NCT01574261 Clinical Trial

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

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01574261
Other study ID # disfunzionale12
Secondary ID
Status Recruiting
Phase Phase 0
First received April 6, 2012
Last updated April 9, 2012
Start date March 2012

Study information
Verified date April 2012
Source Catholic University of the Sacred Heart
Contact Rosanna Apa, M.D.; PhD
Phone 00390630155872
Email sandrina84@hotmail.com
Is FDA regulated No
Health authority Italy: National Institute of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo for four months
• Inositol
Inositol 4g/die for four months

Locations
Country Name City State
Italy Università cattolica S. Cuore Rome

Sponsors (1)
Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Niccoli G, Apa R, Lanzone A, Liuzzo G, Spaziani C, Sagnella F, Cosentino N, Moro F, Martinez D, Morciano A, Bacà M, Pazzano V, Gangale MF, Tropea A, Crea F. CD4+CD28 null T lymphocytes are expanded in young women with polycystic ovary syndrome. Fertil Ste — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary CD4+ CD28 null T-lymphocyte frequency five minutes Yes
Secondary insulinaemic area OGTT AUCi, lipid profile, androgen levels 120 minutes Yes
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