Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

NCT07810998 — Phase 2 / Phase 3, Not yet recruiting, 60 participants, Tanta University

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Registry	NCT07810998
Status	Not yet recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Estimated)
Sponsor	Tanta University (Other)
Conditions	Poly Cystic Ovary Syndrome
Interventions	Metformin, Dapagliflozin (10mg Tab) (Drug)
Dates	start 2026-09-10 (estimated), primary completion 2027-04-30 (estimated), completion 2027-05-10 (estimated), first posted 2026-09-09, last updated 2026-09-09

-Summary

In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals.

Conflicting results exist regarding glucagon-like peptide-1(GLP-1) levels in PCOS patients, with studies reporting reduced, normal, or increased levels. Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with impaired fasting glucose(IFG and impaired glucose tolerance(IGT).

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+Arms and interventions

Arm	Type	Interventions	Description
Metformin arm	Active comparator	Drug: Metformin	Patients will receive Metformin 1000 mg once daily orally for 12 weeks
Dapagliflozin arm	Active comparator	Drug: Dapagliflozin (10mg Tab)	Patients will receive Dapagliflozin 10 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 (PCOS).
Dapagliflozin (10mg Tab) (Drug): Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that promotes urinary glucose and sodium excretion by reducing renal glucose reabsorption. Beyond its established role in type 2 diabetes, dapagliflozin has attracted interest as a potential therapeutic option for polycystic ovary syndrome

+Outcome measures

Primary outcomes

Fertility parameters- Luteinizing hormone [3-months]: Measurement of Luteinizing hormone
Fertility parameters- Follicle stimulating hormone [3-months]: Measurment of Luteinizing hormone
Fertility parameters-Total testosterone [3-months]: Measurement of Total testosterone

+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.

Presence of hypersensitivity to dapagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).

Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors Eating disorders (anorexia, bulimia) or gastrointestinal disorders. Having a history of bariatric surgery.