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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01791647

Enrollment

Registered

2013-02-15

Start date

2011-06-30

Completion date

2012-12-31

Last updated

2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome, myoinositol, metformin, glucose-insulinemic metabolism, menstrual pattern, insulin-lowering therapies

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.

Interventions

DRUGmetformin 1500 mg

DRUGmyoinositol 1500 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

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.

Design outcomes

Primary

Measure	Time frame
number of cycles	six months

Secondary

Measure	Time frame	Description
effects of two therapies on glyco-insulinemic metabolism	six months	Area under the curve insulin post oral glucose tolerance test (μUI/ML/180min), M value of euglycemic hyperinsulinaemic clamp(mg/kg/min).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026