drugset / Trial / NCT07811011
Efficacy of Vildagliptin Versus Metformin in Patients With Polycystic Ovary Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 1000 mg | Oral |
| Comparator | Vildagliptin | Other / unclassified | 50 mg | Oral |