NCT06576375 Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome
| NCT ID | NCT06576375 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Future University in Egypt |
| Condition | Polycystic Ovary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 70 participants in total. It began in 2024-09-02 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06576375 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Polycystic Ovary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06576375 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 70 participants.
Is NCT06576375 currently recruiting?
Yes, NCT06576375 is actively recruiting participants. Contact the research team at nomar@fue.edu.eg for enrollment information.
Where is the NCT06576375 trial being conducted?
This trial is being conducted at Giza, Egypt.
Who is sponsoring the NCT06576375 clinical trial?
NCT06576375 is sponsored by Future University in Egypt. The trial plans to enroll 70 participants.