NCT05601336

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

Effect of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in Infertile Women With Polycystic Ovary Syndrome

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

It is a Prospective randomized controlled trial .The study will include 200 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), according to Rotterdam criteria (BMI≥ 24kg/m, Homeostatic model assessment of insulin resistance (HOMA-IR with cutoff ≥ 2.5 biochemical hyperandrogenism, as indicated by a free androgen index (FAI) \>4, and self-reported oligomenorrhea (cycle length \>35 days and 9 or fewer periods per year) or amenorrhoea (absence of menses for a period ≥3 months) will be included for the study. I The study will include four groups; each group consists of 50 patients:- * Group I (n=50) will be treated by metformin monotherapy. * Group II (n=50) will be treated by Dapagliflozin monotherapy . * Group III (n=50) will be treated by metformin and dapagliflozin combined therapy * Group IV (n=50) will be a control group.

Conditions

• PCO

Interventions

Type	Name	Description
DRUG	Dapagliflozin 5 MG	SGLT2 inhibitor
DRUG	Metformin Hydrochloride 1000 MG	metformin
DRUG	Dapagliflozin/Metformin	SGLT2 inhibitor and metformin HCl extended-release

Timeline

• Start date: 2022-01-15
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2022-11-01
• Last updated: 2023-05-30

Locations

1 site across 1 country: Egypt