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OpenTrials
Completed

NCT Number: NCT06639698

Treatment of Women With PCOS of Phenotype D

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.

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alma Res Fertility Center

Rome, ITA, 00198, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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);
  • Insulin resistance or pre-diabetes condition
  • BMI > 30
  • Endocrinological alterations
  • Chronic pharmacological therapies
  • Major pathological conditions (e.g. tumors or autoimmune diseases)

Treatment and study plan

Diosgenin

Dietary Supplement

Patients will take a tablet containing diosgenin (120 mg), alpha-lactalbumin (100 mg) and vitamin D (50 mcg) - two times per day for six months

Primary outcomes

  1. Restoration of regular menstrual cycle

    Time frame: From enrollment (T0) to the completion of the study at 6 months (T6M)

    Restoration of regular menstrual cycle will be assessed counting the days between two subsequent menstrual cycles, using a menstrual diary updated by the patients

Secondary outcomes

  1. Restoration of physiological appearance of the ovaries at ultrasound

    Time frame: From enrollment (T0) to the completion of the study at 6 months (T6M)

    Reduction of the ultrasonography count of arrested ovarian follicles

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

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

Acronym: PT-PHD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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