of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in PCO

• Status: Recruiting
• Trial end date: 2023-07-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beni-Suef University
• Treatments: Dapagliflozin; Metformin

Criteria

Inclusion Criteria:

• Women are aged between 18 and 45 years

• no pregnancy plan within the next 6 months

• polycystic ovarian syndrome (PCOS), according to Rotterdam criteria

Exclusion Criteria:

1. congenital adrenal hyperplasia

2. poorly controlled thyroid disease

3. Taking antidiabetic drugs which can affect insulin resistance

4. chronic kidney disease and history of recurrent urinary tract infections

5. liver dysfunction (AST or ALT > 3 times the upper limit of normal or GFR<30 ml/min/1.73m2)

6. documented use of oral hormonal contraceptives and hormone-releasing implants