Efficacy of Vildagliptin Versus Metformin in Patients With Polycystic Ovary Syndrome

NCT07811011 — Phase 2 / Phase 3, Not yet recruiting, 70 participants, Tanta University

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Efficacy and Safety of Vildagliptin Versus Metformin in Patients With Polycystic Ovary Syndrome

Registry	NCT07811011
Status	Not yet recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	70 (Estimated)
Sponsor	Tanta University (Other)
Conditions	Poly Cystic Ovary Syndrome
Interventions	Metformin, Vildagliptin (Galvus) (Drug)
Dates	start 2026-09-20 (estimated), primary completion 2027-03-20 (estimated), completion 2027-03-30 (estimated), first posted 2026-09-09, last updated 2026-09-21

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Metformin group	Active comparator	Drug: Metformin	Patients will receive Metformin 1000 mg once daily orally for 12 weeks
Vildagliptin group	Active comparator	Drug: Vildagliptin (Galvus)	Patients will receive vildagliptin 50 mg once daily orally for 12 weeks

Metformin (Drug): Metformin is a widely used insulin-sensitizing agent and one of the most established pharmacological treatments for the metabolic abnormalities associated with polycystic ovary syndrome
Vildagliptin (Galvus) (Drug): Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhances endogenous incretin activity and may improve insulin sensitivity and glucose homeostasis.

+Outcome measures

Primary outcomes

Fertility parameters-Follicle-stimulating hormone [3-months]: Measurement of Follicle-stimulating hormone
Fertility parameters- Luteinizing hormone [3 months]: Measurement of Luteinizing hormone (LH)
Fertility parameters-Free androgen index [3-months]: mesurement of Free androgen index

+Eligibility

Sex: Female, ages: 18 Years to 40 Years

Inclusion Criteria:

Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.

Age: >18 <40 years. Infertile women (primary or secondary infertility)

Exclusion Criteria:

Patients with history of diabetes mellitus (Type 1 or 2). Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease.

Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.

Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.