Treatment of Women With PCOS of Phenotype D

NCT06639698 | Completed

• 1 other identifier: PILOT-PHD-129
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

PCOS phenotype D; Diosgenin; Dioscorea

Outcome Measures

Primary Outcomes (1)

• Restoration of regular menstrual cycle

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

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

Secondary Outcomes (1)

• Restoration of physiological appearance of the ovaries at ultrasound

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

Study Arms (1)

Treatment

EXPERIMENTAL

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

Dietary Supplement: Diosgenin

Interventions

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

Treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lo.Li.Pharma s.r.l: lead

Study Sites (1)

Alma Res Fertility Center

Rome, ITA, 00198, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Diosgenin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Spirostans; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: October 14, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

IT (1)