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

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: NCT01791647
Recruitment Status : Unknown
Verified February 2013 by Maurizio Guido, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart

Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: metformin 1500 mg Drug: myoinositol 1500 mg Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : June 2011
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: myo-inositol
1500 mg/day myoinositol
Drug: myoinositol 1500 mg
Active Comparator: metformin
1500 mg/day of metformin
Drug: metformin 1500 mg

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

Secondary Outcome Measures :
  1. 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).

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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:

  • 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.

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): NCT01791647

Contact: Antonio Lanzone, Professor 063057794

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

Responsible Party: Maurizio Guido, principal investigator, Catholic University of the Sacred Heart Identifier: NCT01791647     History of Changes
Other Study ID Numbers: 000102011
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances