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Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome

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 February 2013 by Maurizio Guido, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01791647
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
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):
Maurizio Guido, Catholic University of the Sacred Heart
  Purpose
The aim of this study is to compare the effects of six months treatment of two insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women affected by polycystic ovary syndrome. The study group includes 40 patients, randomly allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day). The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline and after six months of treatment.

Condition Intervention
Polycystic Ovary Syndrome Drug: metformin 1500 mg Drug: myoinositol 1500 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myo-inositol Versus Metformin: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome

Resource links provided by NLM:


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

Primary Outcome Measures:
  • number of cycles [ Time Frame: six months ]

Secondary Outcome Measures:
  • effects of two therapies on glyco-insulinemic metabolism [ Time Frame: six months ]
    Area under the curve insulin post oral glucose tolerance test (μUI/ML/180min), M value of euglycemic hyperinsulinaemic clamp(mg/kg/min).


Estimated Enrollment: 40
Study Start Date: June 2011
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: myo-inositol
1500 mg/day myoinositol
Drug: myoinositol 1500 mg
Active Comparator: metformin
1500 mg/day of metformin
Drug: metformin 1500 mg

  Eligibility

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
Criteria

Inclusion Criteria:

  • women with Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003;
  • BMI>25 kg/m2;
  • age 18-35 years.

Exclusion Criteria:

  • pregnancy;
  • significant liver or renal impairment;
  • other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs);
  • neoplasms;
  • unstable mental illness;
  • diagnosis of diabetes mellitus or impaired glucose tolerance;
  • use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study.
  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): NCT01791647


Contacts
Contact: Antonio Lanzone, Professor 063057794

Locations
Italy
Catholic University of Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Maurizio Guido, Medical Doctor    063057794      
Principal Investigator: Maurizio Guido, Medical Doctor         
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

Responsible Party: Maurizio Guido, principal investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01791647     History of Changes
Other Study ID Numbers: 000102011
First Submitted: March 12, 2012
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Maurizio Guido, Catholic University of the Sacred Heart:
Polycystic ovary syndrome
myoinositol
metformin
glucose-insulinemic metabolism
menstrual pattern
insulin-lowering therapies

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
Metformin
Inositol
Hypoglycemic Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances