Comparing Dapagliflozin and Metformin for treating Polycystic Ovary Syndrome
Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome: A Prospective Comparative Randomized Blinded Trial.
This study is testing whether Dapagliflozin works better than Metformin for helping non-diabetic women with Polycystic Ovary Syndrome manage their weight and blood sugar levels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Future University in Egypt Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT06576375 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Dapagliflozin compared to Metformin in treating non-diabetic women diagnosed with Polycystic Ovary Syndrome (PCOS). It focuses on the role of incretin hormones in managing glucose levels and weight control in PCOS patients, particularly those who are overweight or obese. The study includes women aged 18 to 40 who meet specific diagnostic criteria for PCOS and excludes those with a history of diabetes or certain other health conditions. The aim is to determine which medication better preserves beta-cell function and reduces the risk of prediabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 40 diagnosed with PCOS who are not diabetic.
Not a fit: Patients with a history of diabetes or those with significant liver or renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women with PCOS, potentially reducing their risk of developing diabetes.
How similar studies have performed: Previous studies have explored incretin-based therapies in similar populations, but this specific comparison of Dapagliflozin and Metformin in PCOS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Giza
- October 6 University Hospital — Giza, Egypt (Recruiting)
Study contacts
- Study coordinator: Nouran Omar
- Email: nomar@fue.edu.eg
- Phone: 01006526452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.