Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome
ConditionPolycystic Ovary Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorFuture University in Egypt
About this trial
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
Qualifiers
Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
Age: >18 <40 years.
Infertile women (primary or secondary infertility)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Dapagliflozin
- Metformin
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Future University in Egypt
Lead sponsor
October 6 University
Collaborator
Source ClinicalTrials.gov