Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome | Drug: Placebo Drug: Inositol | Early Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Inositol
Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment
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Drug: Inositol
Inositol 4g/die for four months |
Placebo Comparator: Placebo
Patients will be randomized to receive placebo for four months
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Drug: Placebo
Placebo for four months |
- CD4+ CD28 null T-lymphocyte frequency [ Time Frame: five minutes ]
- insulinaemic area OGTT AUCi, lipid profile, androgen levels [ Time Frame: 120 minutes ]

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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).

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 ClinicalTrials.gov identifier (NCT number): NCT01574261
Contact: Rosanna Apa, M.D.; PhD | 00390630155872 | sandrina84@hotmail.com |
Italy | |
Università cattolica S. Cuore | Recruiting |
Rome, Italy, 00168 |
Responsible Party: | Rosanna Apa, Professor, Catholic University of the Sacred Heart |
ClinicalTrials.gov 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 |
Polycystic Ovary Syndrome Cardiovascular risk Metabolic Syndrome |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases |
Gonadal Disorders Endocrine System Diseases Inositol Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |