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

NCT01791647 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-07-24

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

metformin 1500 mg

DRUG

myoinositol 1500 mg

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01791647 on ClinicalTrials.gov