Clinical trial · Interventional
Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone
Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone: 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)
Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hirsutism | — | UNRESOLVED | — |
| Menstrual Irregularity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| myo-inositol 1500 gr | Drug | — | UNRESOLVED |
| myo-inositol 2000 gr + folic acid 200 mcg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- myo-inositol 1500 gr
- description
- 6 months treatment with myo-inositol 1500 gr
- interventionNames
- Drug: myo-inositol 1500 gr
- type
- ACTIVE_COMPARATOR
- label
- myo-inositol 2000gr + folic acid 200 mcg
- interventionNames
- Drug: myo-inositol 2000 gr + folic acid 200 mcg
Primary outcomes (1)
- measure
- number of cycles in six months of therapy
- timeFrame
- 6 months
- description
- We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * women with PCOS 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 dysfunctions (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 entering the study.
References
Publications (0)
Data not yet available