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

April 7, 2025 updated by: Lo.Li.Pharma s.r.l

Treatment of Women With Different Phenotype of Polycystic Ovary Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • ITA
      • Rome, ITA, Italy, 00198
        • Alma Res Fertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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)
Myo-inositol and D-chiro-inositol (40:1 ratio), 2 grams (twice a day) for three months
Other Names:
  • 40:1
Active Comparator: 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)
Myo-inositol and D-chiro-inositol (3.6:1 ratio), 1.4 grams (once daily) for three months
Other Names:
  • 3.6:1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration of regular menstrual cycle
Time Frame: 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
From enrollment (T0) to the completion of the study at 3 months (T3M)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lo.Li.Pharma s.r.l

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

March 6, 2025

Study Completion (Actual)

March 14, 2025

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ino-ratio_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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