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Recruiting
NCT05601336
of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in PCO
Conditions: PCO
Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 200
Sponsor: Beni-Suef University
Location: Egypt
Summary
The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and dapagliflozin as monotherapies and the effect of both of them as a combined therapy in infertile women with PCOs.
Eligibility Criteria
Inclusion Criteria:Women are aged between 18 and 45 yearsno pregnancy plan within the next 6 monthspolycystic ovarian syndrome (PCOS), according to Rotterdam criteriaExclusion Criteria:congenital adrenal hyperplasiapoorly controlled thyroid diseaseTaking antidiabetic drugs which can affect insulin resistancechronic kidney disease and history of recurrent urinary tract infectionsliver dysfunction (AST or ALT > 3 times the upper limit of normal or GFR<30 ml/min/1.73m2)documented use of oral hormonal contraceptives and hormone-releasing implants
Source: ClinicalTrials.gov (NCT05601336). StuddyBuddy aggregates publicly available trial information.