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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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myo-inositol

1500 mg/day myoinositol

Group Type ACTIVE_COMPARATOR

myoinositol 1500 mg

Intervention Type DRUG

metformin

1500 mg/day of metformin

Group Type ACTIVE_COMPARATOR

metformin 1500 mg

Intervention Type DRUG

Interventions

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metformin 1500 mg

Intervention Type DRUG

myoinositol 1500 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes