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NCT06715527Completed

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

Treatment of Women With Different Phenotype of Polycystic Ovary Syndrome

Source: ClinicalTrials.gov · Last updated 8 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
28 Nov 2024
Start date
1 Nov 2024
Primary completion date
6 Mar 2025
Lead sponsor
Lo.Li.Pharma s.r.l
NCT number
NCT06715527

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 1 Nov 2024 to the primary completion date, 6 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • use of medications that influence ovulation
  • chronic pharmacological therapies

Other illness

  • other causes of hyperandrogenism (e.g., adrenal hyperplasia or Cushing's syndrome)

Other

  • other causes of ovulatory disfunction (e.g., hyperprolactinemia or hypothyroidism)
  • hormonal treatments
  • use of inositol-containing supplements
  • regular consumption of inositol-enriched food

Who the study is looking for

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

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Alma Res Fertility Center
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.