Clinical trial · Interventional
Treatment of Women With Hyperandrogenic PCOS With Two Different Ratios of Myo-inositol:D-chiro-inositol: A Comparison
Treatment of Women With Different Phenotype of 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)
In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study. Current treatments for PCOS include insulin sensitizers (such as metformin) and hormonal contraceptives. However, they are not devoid of side effects or may not be well tolerated, often leading to therapy discontinuation. Inositol represents a valid alternative to standard treatments, as it serves both as insulin sensitizer and as second messenger of FSH in the ovaries, thus regulating glucose metabolism and supporting ovarian function. The presence of two inositol isomers, namely myo-inositol and D-chiro-inositol, in defined ratios in human tissues suggests that supplementation with both would be ideal. Despite numerous evidence available, the ratio that gives the best clinical results is still debated. In the present clinical trial, patients will be given a dietary supplement containing myo-inositol and D-chiro-inositol in two ratios (either 40:1 or 3.6:1, respectively) for three months. Restoration of regular menstrual cycle and of hormonal status will be the primary goal of the intervention.
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 Ovarian Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Myo-Inositol and D-Chiro-Inositol (3.6:1) | Dietary Supplement | — | UNRESOLVED |
| Myo-Inositol and D-Chiro-Inositol (40:1) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 40:1 ratio
- interventionNames
- Dietary Supplement: Myo-Inositol and D-Chiro-Inositol (40:1)
- type
- ACTIVE_COMPARATOR
- label
- Comparator
- description
- Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 3.6:1 ratio
- interventionNames
- Dietary Supplement: Myo-Inositol and D-Chiro-Inositol (3.6:1)
Primary outcomes (1)
- measure
- Restoration of regular menstrual cycle
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * PCOS according to the Rotterdam Criteria * Clinical or biochemical hyperandrogenism Exclusion Criteria: * other causes of ovulatory disfunction (e.g., hyperprolactinemia or hypothyroidism) * other causes of hyperandrogenism (e.g., adrenal hyperplasia or Cushing's syndrome) * use of medications that influence ovulation * hormonal treatments * chronic pharmacological therapies * use of inositol-containing supplements * regular consumption of inositol-enriched food
References
Publications (0)
Data not yet available