Treatment of Women with PCOS of Phenotype D

Last updated: October 16, 2024
Sponsor: Lo.Li.Pharma s.r.l
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

Diosgenin

Clinical Study ID

NCT06639698
PILOT-PHD-129
  • Ages 18-45
  • Female

Study Summary

In this study, female patients diagnosed with PCOS of phenotype D will be enrolled. They generally display the following characteristics: menstrual cycle alterations; polycystic ovary morphology at ultrasound; normal blood levels of androgen, particularly testosterone; no signs of clinical hyperandrogenism.

Current treatments for this condition include insulin sensitizers (such as metformin) and hormonal contraceptives. However, this specific phenotype of PCOS do not feature metabolic or hormonal alterations, and the efficacy of these treatments has lately been questioned.

In the present clinical trial, patients will be given a dietary supplement containing Dioscorea extract (source of Diosgenin, a natural analog of progesterone), vitamin D and alpha-lactalbumin for six month. Restoration of regular menstrual cycle and physiological ultrasound appearance of the ovaries will be the primary goal of the intervention.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of PCOS of phenotype D, according to the Rotterdam Criteria and theEGOI-PCOS Criteria

Exclusion

Exclusion Criteria:

  • Diagnosis of PCOS of phenotype A, B or C, according to the Rotterdam Criteria andthe EGOI-PCOS Criteria

  • Hormonal treatments;

  • Treatments with inositol or other insulin sensitizers (such as metformin);

  • Insulin resistance or pre-diabetes condition

  • BMI > 30

  • Endocrinological alterations

  • Chronic pharmacological therapies

  • Major pathological conditions (e.g. tumors or autoimmune diseases)

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Diosgenin
Phase:
Study Start date:
October 14, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Alma Res Fertility Center

    Rome, ITA 00198
    Italy

    Active - Recruiting

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