Status:
RECRUITING
Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome
Lead Sponsor:
Future University in Egypt
Collaborating Sponsors:
October 6 University
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
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 pepti...
Detailed Description
Incretins such as glucagon-like peptide-1(GLP-1) are gut hormones secreted after meals that enhance insulin secretion and help maintain glucose homeostasis.They also reduce hepatic glucagon release, s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06576375
Start Date
September 2 2024
End Date
January 1 2025
Last Update
October 22 2024
Active Locations (1)
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1
October 6 University Hospital
Giza, Egypt