Treatment of Women With Hyperandrogenic PCOS With Two Different Ratios of Myo-inositol:D-chiro-inositol: A Comparison

Not Applicable

Completed

• Conditions: Polycystic Ovarian Syndrome (PCOS)

• Registration Number: NCT06715527
• Lead Sponsor: Lo.Li.Pharma s.r.l

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-04
• Primary Completion: 2025-03-06
• Study Completion: 2025-03-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Restoration of regular menstrual cycle	From enrollment (T0) to the completion of the study at 3 months (T3M)	Number (%) of patients with regular menstrual cycle at the end of the study

Secondary Outcome Measures

Name	Time	Method
Hormonal status	From enrollment (T0) to the completion of the study at 3 months (T3M)	Changes of serum hormonal levels (Progesterone; FSH; LH; Estradiol; Testosterone; Insulin)

Trial Locations

Locations (1)

Alma Res Fertility Center; 🇮🇹 Rome, ITA, Italy