drugset / Trial / NCT07811011

Efficacy of Vildagliptin Versus Metformin in Patients With Polycystic Ovary Syndrome

NCT07811011 ↗

Phase 2/3 Not yet recruiting 70 enrolled Tanta University
RandomizedParallel-groupDouble-blindTreatment

Summary

Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology, with insulin resistance playing a central role in its pathophysiology. Hyperinsulinemia can enhance ovarian androgen production and reduce hepatic sex hormone-binding globulin synthesis, thereby aggravating hyperandrogenism and reproductive abnormalities. Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhances endogenous incretin activity and may improve insulin sensitivity and glucose homeostasis. Emerging evidence suggests that DPP-4 inhibition may also influence body weight, androgen excess, inflammation, and reproductive function in women with PCOS.

Timeline

Start
2026-09-20
Primary completion
2027-03-20
Completion
2027-03-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1000 mg Oral
Comparator Vildagliptin Other / unclassified 50 mg Oral