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

PCO Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05601336
• Other study ID #: REC-H-PhBSU-22012
• Status: Recruiting
• Phase: Phase 3
• Start date: January 15, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: May 2023
• Source: Beni-Suef University
• Contact: Sara A Salem, MD
• Phone: 01272842226
• Email: sara_abdallah100[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• PCO

Intervention

Drug:
• Dapagliflozin 5 MG
SGLT2 inhibitor
• Metformin Hydrochloride 1000 MG
metformin
• Dapagliflozin/Metformin
SGLT2 inhibitor and metformin HCl extended-release

Locations

Country	Name	City	State
Egypt	Beni-suef university	Bani Suwayf	Beni Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovulation	folliculometry by ultrasound	3 cycles ( 3 months / one month for each cycle)
Primary	Cummulative rate of pregnancy	HCG test	3 months
Secondary	Body weight changes	weight loss by Kg	3 months
Secondary	changes of Menstrual cycle	history from the patient	3 months
Secondary	Fasting blood sugar (FBS)/ 2 hpp		3 months
Secondary	Free Androgen Index (FAI)		3 months
Secondary	Total Testosterone (TT)		3 months
Secondary	FSH*LH*E2		3 months
Secondary	lipid profile		3 months
Secondary	ALT		3 months
Secondary	side effects	Number of patients will report nausea / diarrhea/ lactic acidosis	3 months