NCT06639698

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Lo.Li.Pharma s.r.l · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Diosgenin	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

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-05-30
• Completion: 2025-06-30
• First posted: 2024-10-15
• Last updated: 2025-07-25

Locations

1 site across 1 country: Italy