Efficacy of Vildagliptin Versus Metformin in Patients With Polycystic Ovary Syndrome

NCT07811011 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: KO145
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Poly Cystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

• Fertility parameters-Follicle-stimulating hormone

  Measurement of Follicle-stimulating hormone

  3-months

• Fertility parameters- Luteinizing hormone

  Measurement of Luteinizing hormone (LH)

  3 months

• Fertility parameters-Free androgen index

  mesurement of Free androgen index

  3-months

Study Arms (2)

Metformin group

ACTIVE COMPARATOR

Patients will receive Metformin 1000 mg once daily orally for 12 weeks

Drug: Metformin

Vildagliptin group

ACTIVE COMPARATOR

Patients will receive vildagliptin 50 mg once daily orally for 12 weeks

Drug: Vildagliptin (Galvus)

Interventions

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

Metformin group

Vildagliptin (Galvus) DRUG

Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhances endogenous incretin activity and may improve insulin sensitivity and glucose homeostasis.

Vildagliptin group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
• Age: \>18 \<40 years. Infertile women (primary or secondary infertility)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Interventions

Metformin; Vildagliptin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nitriles; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mostafa M Bahaa, PhD

CONTACT

0201025538337; mbahaa@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09