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

NCT06715527 | Completed

• 1 other identifier: Ino-ratio_2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Keywords

PCOS; myo-inositol; D-chiro-inositol; menstual cycle

Outcome Measures

Primary Outcomes (1)

• Restoration of regular menstrual cycle

  Number (%) of patients with regular menstrual cycle at the end of the study

  From enrollment (T0) to the completion of the study at 3 months (T3M)

Secondary Outcomes (1)

• Hormonal status

  From enrollment (T0) to the completion of the study at 3 months (T3M)

Study Arms (2)

Treatment

EXPERIMENTAL

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

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

Comparator

ACTIVE COMPARATOR

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

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

Interventions

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

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

Also known as: 40:1

Treatment

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

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

Also known as: 3.6:1

Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PCOS according to the Rotterdam Criteria
• Clinical or biochemical hyperandrogenism

You may not qualify if:

• 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

Sponsors & Collaborators

• Lo.Li.Pharma s.r.l: lead

Study Sites (1)

Alma Res Fertility Center

Rome, ITA, 00198, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Inositol

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: November 1, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 14, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)