CompletedPhase 3
Dapagliflozin Versus Metformin and Their Combination in Polycystic Ovary Syndrome
Key facts
- Who runs it
- Beni-Suef University
- Where
- Egypt1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 200 people enrolled
- Started
- 15 May 2025
- Ended
- 30 May 2026
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dapagliflozin 5 MG
- Metformin Hydrochloride 1000 MG
- Dapagliflozin/Metformin
- Record updated
- 15 October 2026
Who can take part
- Age
- 20 years to 45 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Women are aged between 20 and 45 years
- polycystic ovarian syndrome (PCOS), according to Rotterdam criteria
Who cannot take part
- Taking antidiabetic drugs which can affect insulin resistance
- documented use of oral hormonal contraceptives and hormone-releasing implants
- poorly controlled thyroid disease
- chronic kidney disease and history of recurrent urinary tract infections
- liver dysfunction (AST or ALT > 3 times the upper limit of normal or GFR<30 ml/min/1.73m2)
- congenital adrenal hyperplasia
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 women with PCOs.
The 4 groups in the trial
- metformin monotherapyExisting treatment, for comparison
Glucophage 1000 once daily
Treatment: Metformin Hydrochloride 1000 MG
- Dapagliflozin monotherapy .Existing treatment, for comparison
Farxiga once per day
Treatment: Dapagliflozin 5 MG
- metformin and dapagliflozin combined therapyExisting treatment, for comparison
Xigduo once daily
Treatment: Dapagliflozin/Metformin
- control group.No study treatment, for comparison
control
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in Women With Polycystic Ovary Syndrome
- Record updated
- 15 October 2026