Efficacy of Vildagliptin Versus Metformin in Patients With Polycystic Ovary Syndrome

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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Key information

Conditions

Poly Cystic Ovary Syndrome

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Fertility parameters-Follicle-stimulating hormone

Time frame: 3-months

Measurement of Follicle-stimulating hormone
Fertility parameters- Luteinizing hormone

Time frame: 3 months

Measurement of Luteinizing hormone (LH)
Fertility parameters-Free androgen index

Time frame: 3-months

mesurement of Free androgen index

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Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 9, 2026
Registry last updated: Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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