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NCT Number: NCT01791647

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Sacred Heart

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin 1500 mg

Drug

myoinositol 1500 mg

Drug

Primary outcomes

  1. number of cycles

    Time frame: six months

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

Myo-inositol Versus Metformin: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2013
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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