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

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.

Study Overview

• Status: Recruiting
• Conditions: PCO
• Intervention / Treatment: Drug: Metformin Hydrochloride 1000 MG; Drug: Dapagliflozin 5 MG; Drug: Dapagliflozin/Metformin

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sara A Salem, MD; Phone Number: 02 01272842226; Email: sara_abdallah100@yahoo.com

Study Locations

• Egypt
  • Beni Suef
    • Banī Suwayf, Beni Suef, Egypt, 62521
      • Recruiting
      • Beni-Suef University
      • Contact: Beni Suef University; Phone Number: 082 2356845; Email: info@bsu.edu.eg
      • Principal Investigator: Sara A Salem, MD
      • Sub-Investigator: Mahmoud M Mahmoud, Bachelor
      • Sub-Investigator: Rania M Hussein, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: metformin monotherapy; Glucophage 1000 once daily	Drug: Metformin Hydrochloride 1000 MG; metformin; Other Names: Glucophage 1000mg
Active Comparator: Dapagliflozin monotherapy .; Farxiga once per day	Drug: Dapagliflozin 5 MG; SGLT2 inhibitor; Other Names: [Farxiga]
Active Comparator: metformin and dapagliflozin combined therapy; Xigduo once daily	Drug: Dapagliflozin/Metformin; SGLT2 inhibitor and metformin HCl extended-release; Other Names: Xigduo
No Intervention: control group.; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cummulative rate of pregnancy	HCG test	3 months
ovulation	folliculometry by ultrasound	3 cycles ( 3 months / one month for each cycle)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Study Director: Beni-Suef University, Clinical Pharmacy Faculty of Pharmacy Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Estimated): July 30, 2023
• Study Completion (Estimated): July 30, 2023

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin; Metformin
• Other Study ID Numbers: REC-H-PhBSU-22012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: within 36 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No