Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

Sponsor
Tanta University
Study ID
NCT07810998
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Poly Cystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

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 (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

Study Details

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).

Key Dates

First listed
Sep 9, 2026
Start date
Sep 10, 2026
Status verified
Sep 2026
Primary completion
Apr 30, 2027
Completion
May 10, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metformin arm
    Patients will receive Metformin 1000 mg once daily orally for 12 weeks
  • Active Comparator: Dapagliflozin arm
    Patients will receive Dapagliflozin 10 mg once daily orally for 12 weeks

Primary Outcome Measure

Fertility parameters- Luteinizing hormone [ Time Frame: 3-months ]

Central Contacts

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