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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006991-31-IT

Enrollment

Registered

2009-06-19

Start date

2009-06-11

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

polycystic ovary syndrome MedDRA version: 12.0 Level: LLT Classification code 10036049 Term: Polycystic ovaries

Interventions

Trade Name: METFORAL Pharmaceutical Form: Tablet INN or Proposed INN: Metformin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 850- Pharmaceutical Form: Oral powd

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026