Clinical trial NCT05601336: of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in PCO
Official title: Effect of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in Infertile Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: PCO
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ovulation
timeFrame: 3 cycles ( 3 months / one month for each cycle)
measure: Cummulative rate of pregnancy
timeFrame: 3 months
Secondary outcomes:
measure: Body weight changes
timeFrame: 3 months
measure: changes of Menstrual cycle
timeFrame: 3 months
measure: Fasting blood sugar (FBS)/ 2 hpp
timeFrame: 3 months
measure: Free Androgen Index (FAI)
timeFrame: 3 months
measure: Total Testosterone (TT)
timeFrame: 3 months
measure: FSH*LH*E2
timeFrame: 3 months
measure: lipid profile
timeFrame: 3 months
measure: ALT
timeFrame: 3 months
measure: side effects
timeFrame: 3 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university
state: Beni Suef
Study officials:
affiliation: Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
name: Beni-Suef University
role: STUDY_DIRECTOR
References: