Clinical trial · Interventional
Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome
Myo-inositol Versus Metformin: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metformin 1500 mg | Drug | Metformin | ALIAS |
| myoinositol 1500 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- myo-inositol
- description
- 1500 mg/day myoinositol
- interventionNames
- Drug: myoinositol 1500 mg
- type
- ACTIVE_COMPARATOR
- label
- metformin
- description
- 1500 mg/day of metformin
- interventionNames
- Drug: metformin 1500 mg
Primary outcomes (1)
- measure
- number of cycles
- timeFrame
- six months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available