PCO
Conditions
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 women with PCOs.
Detailed description
It is a Prospective randomized controlled trial .The study will include 200 randomly selected infertile women aged between 20 and 45 years, whom diagnosed with polycystic ovarian syndrome (PCOS), according to Rotterdam criteria 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.
Interventions
SGLT2 inhibitor
metformin
SGLT2 inhibitor and metformin HCl extended-release
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women are aged between 20 and 45 years * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOMA IR | 3 months | Insulin resistance is assessed using HOMA IR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight changes | 3 months | weight loss by Kg |
| Fasting blood sugar (FBS) | 3 months | — |
| Total Testosterone (TT) | 3 months | — |
| lipid profile | 3 months | — |
| side effects | 3 months | Number of patients will report nausea / diarrhea |
Countries
Egypt
Contacts
STUDY_DIRECTORBeni-Suef University
Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
Outcome results
None listed