We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 Rosanna Apa, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01574261
First Posted: April 10, 2012
Last Update Posted: April 10, 2012
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.
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart
  Purpose
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 (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Rosanna Apa, 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT01574261


Contacts
Contact: Rosanna Apa, M.D.; PhD 00390630155872 sandrina84@hotmail.com

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

Publications:
Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01574261     History of Changes
Other Study ID Numbers: disfunzionale12
First Submitted: April 6, 2012
First Posted: April 10, 2012
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:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs