Effect of the combined treatment with myo-inositol and metformin on the phenotype of the polycystic ovary syndrome: a pilot study - UOE/08/03

Conditions: polycystic ovary syndrome
MedDRA version: 12.0Level: LLTClassification code 10036049Term: Polycystic ovaries

Registration Number: EUCTR2008-006991-31-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria are: i) diagnosis of PCOS according to the National Institutes of Health (NIH) 1999 criteria; ii) body Mass Index (BMI) (Kg/m2) values greater than 19 and lower than or equal to 27 kg/m2; iii) age between 18 and 44 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria are: i) diabetes in insulin failure; ii) renal, hepatic, or cardiac chronic diseases; iii) low compliance; iv) chronic uses of drugs; v) menopause; vi) Pregnancy or breast-feeding, or women planning to become pregnant (excluded by pregnancy test); vii) Unability to follow the procedures set by the Protocol and to sign the informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary aim of the study is to evaluate the impact of 6 months treatment with myo-inositol and metformin on insulin resistance of women with the polycystic ovary syndrome (PCOS) when compared with myo-inositol or metformin alone;Secondary Objective: Secondary mains are to evaluate the impact of the combined therapy myo-inositol plus metformin on other parameters of the PCOS, i.e. menses and ovulation, hyperandrogenism and hyperandrogenemia, metabolic profile and cardiovascular risk factors, ovarian morphology.;Primary end point(s): This study has bees designed to demonstrate the superiority of the combined treatment myo-inositol plus metformin on insulin resistance of PCOS women with respect to the monotherapies.

Secondary Outcome Measures