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

Phase 3

Recruiting

• Conditions: PCO
• Interventions: Drug: Dapagliflozin 5 MG; Drug: Dapagliflozin/Metformin; Drug: Metformin Hydrochloride 1000 MG

• Registration Number: NCT05601336
• Lead Sponsor: Beni-Suef University

Brief 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.

Study Timeline

• Study Start: 2022-01-15
• Study First Submitted: 2022-10-15
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-11-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-30
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin monotherapy .	Dapagliflozin 5 MG	Farxiga once per day
metformin and dapagliflozin combined therapy	Dapagliflozin/Metformin	Xigduo once daily
metformin monotherapy	Metformin Hydrochloride 1000 MG	Glucophage 1000 once daily

Primary Outcome Measures

Name	Time	Method
Cummulative rate of pregnancy	3 months	HCG test
ovulation	3 cycles ( 3 months / one month for each cycle)	folliculometry by ultrasound

Secondary Outcome Measures

Name	Time	Method
ALT	3 months
Body weight changes	3 months	weight loss by Kg
Fasting blood sugar (FBS)/ 2 hpp	3 months
FSH*LH*E2	3 months
Total Testosterone (TT)	3 months
lipid profile	3 months
side effects	3 months	Number of patients will report nausea / diarrhea/ lactic acidosis
Free Androgen Index (FAI)	3 months
changes of Menstrual cycle	3 months	history from the patient

Trial Locations

Locations (1)

Beni-suef university; 🇪🇬 Banī Suwayf, Beni Suef, Egypt