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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01574261
Recruitment Status : Unknown
Verified April 2012 by Rosanna Apa, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : April 10, 2012
Last Update Posted : April 10, 2012
Information provided by (Responsible Party):
Rosanna Apa, 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Placebo Drug: Inositol Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2012
Estimated Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Arm Intervention/treatment
Active Comparator: Inositol
Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment
Drug: Inositol
Inositol 4g/die for four months

Placebo Comparator: Placebo
Patients will be randomized to receive placebo for four months
Drug: Placebo
Placebo for four months

Primary Outcome Measures :
  1. CD4+ CD28 null T-lymphocyte frequency [ Time Frame: five minutes ]

Secondary Outcome Measures :
  1. insulinaemic area OGTT AUCi, lipid profile, androgen levels [ Time Frame: 120 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01574261

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Contact: Rosanna Apa, M.D.; PhD 00390630155872

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Università cattolica S. Cuore Recruiting
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Publications of Results:
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Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart Identifier: NCT01574261    
Other Study ID Numbers: disfunzionale12
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by Rosanna Apa, Catholic University of the Sacred Heart:
Polycystic Ovary Syndrome
Cardiovascular risk
Metabolic Syndrome
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs