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

Beni-Suef University

Status and phase: Enrolling; Phase 3

Conditions: PCO

Treatments: Drug: Dapagliflozin/Metformin; Drug: Metformin Hydrochloride 1000 MG; Drug: Dapagliflozin 5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05601336

REC-H-PhBSU-22012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 4 patient groups

metformin monotherapy

Active Comparator group

Description:

Glucophage 1000 once daily

Treatment:

Drug: Metformin Hydrochloride 1000 MG

Dapagliflozin monotherapy .

Active Comparator group

Description:

Farxiga once per day

Treatment:

Drug: Dapagliflozin 5 MG

metformin and dapagliflozin combined therapy

Active Comparator group

Description:

Xigduo once daily

Treatment:

Drug: Dapagliflozin/Metformin

control group.

No Intervention group

Description:

placebo