Completed

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

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What is being tested

myoinositol 1500 mg

+ metformin 1500 mg

Drug
Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Adnexal Diseases

From 18 to 35 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2011
See protocol details

Summary

Principal SponsorCatholic University of the Sacred Heart
Last updated: July 24, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01791647
Principal SponsorCatholic University of the Sacred Heart
Last updated: July 24, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCystsEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGonadal DisordersNeoplasmsOvarian CystsOvarian DiseasesFemale Urogenital DiseasesPolycystic Ovary Syndrome

Criteria

3 inclusion criteria required to participate
BMI > 25 kg/m2
age 18-35 years
women with Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003
7 exclusion criteria prevent from participating
diagnosis of diabetes mellitus or impaired glucose tolerance
neoplasms
other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
pregnancy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
1500 mg/day myoinositol

Group II

Active Comparator
1500 mg/day of metformin

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Catholic University of Sacred Heart

Rome, ItalyOpen Catholic University of Sacred Heart in Google Maps
CompletedOne Study Center