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

NCT ID: NCT06715527

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-03-14

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.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 40:1 ratio

Group Type: EXPERIMENTAL

Myo-Inositol and D-Chiro-Inositol (40:1)

Intervention Type: DIETARY_SUPPLEMENT

Myo-inositol and D-chiro-inositol (40:1 ratio), 2 grams (twice a day) for three months

Comparator

Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 3.6:1 ratio

Group Type: ACTIVE_COMPARATOR

Myo-Inositol and D-Chiro-Inositol (3.6:1)

Intervention Type: DIETARY_SUPPLEMENT

Myo-inositol and D-chiro-inositol (3.6:1 ratio), 1.4 grams (once daily) for three months

Interventions

Myo-Inositol and D-Chiro-Inositol (40:1)

Myo-inositol and D-chiro-inositol (40:1 ratio), 2 grams (twice a day) for three months

Intervention Type: DIETARY_SUPPLEMENT

Myo-Inositol and D-Chiro-Inositol (3.6:1)

Myo-inositol and D-chiro-inositol (3.6:1 ratio), 1.4 grams (once daily) for three months

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

40:1; 3.6:1

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alma Res Fertility Center

Rome, ITA, Italy

Countries

Italy

Other Identifiers

Ino-ratio_2024

Identifier Type: -

Identifier Source: org_study_id