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NCT06639698Completed

Treatment of Women With PCOS of Phenotype D

Treatment of Menstrual Cycle Alterations in Women With PCOS of Phenotype D Using Dietary Supplementation That Combines Diosgenin, Vitamin D and Alpha-lactalbumin

Source: ClinicalTrials.gov · Last updated 25 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
24 (actual)
First submitted
11 Oct 2024
Start date
14 Oct 2024
Primary completion date
30 May 2025
Lead sponsor
Lo.Li.Pharma s.r.l
NCT number
NCT06639698

What you commit to

  • Study type: Interventional
  • Participants enrolled: 24
  • From 14 Oct 2024 to the primary completion date, 30 May 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

  • Chronic pharmacological therapies

Other illness

  • Insulin resistance or pre-diabetes condition
  • Major pathological conditions (e.g. tumors or autoimmune diseases)

Other

  • Diagnosis of PCOS of phenotype A, B or C, according to the Rotterdam Criteria and the EGOI-PCOS Criteria
  • Hormonal treatments;
  • Treatments with inositol or other insulin sensitizers (such as metformin);
  • BMI \> 30
  • Endocrinological alterations

Who the study is looking for

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

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.