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NCT06715527
Treatment of Women With Hyperandrogenic PCOS With Two Different Ratios of Myo-inositol:D-chiro-inositol: A Comparison
NA trial testing Myo-Inositol and D-Chiro-Inositol (40:1) in Polycystic Ovarian Syndrome (PCOS) in 30 participants. Completed in 14 March 2025.
6 March 2025
Quick facts
| Lead sponsor | Lo.Li.Pharma s.r.l |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 November 2024 |
| Primary completion | 6 March 2025 |
| Estimated completion | 14 March 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Myo-Inositol and D-Chiro-Inositol (40:1)
- Myo-Inositol and D-Chiro-Inositol (3.6:1)
Conditions studied
- Polycystic Ovarian Syndrome (PCOS) — all drugs for Polycystic Ovarian Syndrome (PCOS) →
Sponsor
Lo.Li.Pharma s.r.l
Who can join
Adults 18 to 45, female only, with Polycystic Ovarian Syndrome (PCOS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06715527
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Polycystic Ovarian Syndrome (PCOS)
Currently open trials in the same condition.
- NCT07392476 — Continuous Glucose Monitoring in Polycystic Ovarian Syndrome · active not recruiting
- NCT07157371 — Effects of Aerobic Exercise Training Program in Females With Insulin Resistant Polycystic Ovarian Syndrome · NA · active not recruiting
- NCT07399535 — Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome · Phase 1 · recruiting
Other Lo.Li.Pharma s.r.l trials
Trials by the same sponsor.
- NCT07257770 — Local Treatment of Breast Pain Based on the Daily Use of a Topical Gel · NA · recruiting
- NCT06639698 — Treatment of Women With PCOS of Phenotype D · NA · completed
- NCT05674318 — The Effect of Alpha-lactalbumin on Microbiota Composition · NA · completed
- NCT05678114 — Inositol Treatment in Different Type of PCOS Phenotype · NA · completed
- NCT06057896 — Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06715527 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lo.Li.Pharma s.r.l
- Last refreshed: 8 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06715527.
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