Efficacy of Dapagliflozin Versus Metformin in Patients With Polycystic Ovary Syndrome

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

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07811011

Enrollment

Registered

2026-09-09

Start date

2026-09-20

Completion date

2027-03-30

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poly Cystic Ovary Syndrome

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.

Interventions

DRUGMetformin

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

DRUGVildagliptin (Galvus)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double blinded

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

CONTACTMostafa M Bahaa, PhD

mbahaa@horus.edu.eg0201025538337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026