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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart Identifier:
First received: April 6, 2012
Last updated: April 9, 2012
Last verified: April 2012
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 Intervention Phase
Polycystic Ovary Syndrome
Drug: Placebo
Drug: Inositol
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Catholic University of the Sacred Heart:

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

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

Estimated Enrollment: 70
Study Start Date: March 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01574261

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

Università cattolica S. Cuore Recruiting
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart Identifier: NCT01574261     History of Changes
Other Study ID Numbers: disfunzionale12
Study First Received: April 6, 2012
Last Updated: April 9, 2012

Keywords provided by Catholic University of the Sacred Heart:
Polycystic Ovary Syndrome
Cardiovascular risk
Metabolic Syndrome

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on May 25, 2017