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Clinical Trials/NCT06715527
NCT06715527
Completed
Not Applicable

Treatment of Women With Different Phenotype of Polycystic Ovary Syndrome

Lo.Li.Pharma s.r.l1 site in 1 country30 target enrollmentNovember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polycystic Ovarian Syndrome (PCOS)
Sponsor
Lo.Li.Pharma s.r.l
Enrollment
30
Locations
1
Primary Endpoint
Restoration of regular menstrual cycle
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
March 14, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Study Sites (1)

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