Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

Sponsor
Future University in Egypt
Study ID
NCT06576375
Phase
PHASE3
Status
Recruiting
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Conditions

  • Polycystic Ovary Syndrome

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    oral Dapagliflozin
  • Metformin — DRUG
    oral metformin

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). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).

Key Dates

Start date
Sep 2, 2024
Status verified
Aug 2024
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025

Study Design

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

Arms

  • Active Comparator: Dapagliflozin
    Patients will receive Dapagliflozin 10 mg once daily orally for 12 weeks (Forxiga® AstraZeneca company)
  • Active Comparator: Metformin
    Patients will receive Metformin 1000 mg once daily orally for 12 weeks (control group) (Glucophage® Merck company)

Primary Outcome Measure

Fertility parameters- Luteinizing hormone [ Time Frame: 3-6 months ]

Central Contacts

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