Polycystic Ovary Syndrome (PCOS)
Conditions
Keywords
PCOS, Empagliflozin, Linagliptin, Metformin
Brief summary
The study aims to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
Detailed description
Patients with polycystic ovary syndrome will be randomized to three arms: * Metformin (standard care) * Empagliflozin or Linagliptin Resolution of the syndrome in addition to normalization of sex hormones, metabolic and inflammatory parameters will be tested
Interventions
DRUGEmpagliflozin 25 mg
This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)
DRUGLinagliptin 10 mg
This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)
This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Women diagnosed with PCOS according to National Institute of Health criteria. 2. Age: \>18 \<40 years. 3. Infertile women (primary or secondary infertility).
Exclusion criteria
1. Patients with history of diabetes mellitus (Type 1 or 2). 2. Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease. 3. Significantly elevated triglyceride levels (fasting triglyceride \> 400 mg/dL) 4. Untreated or poorly controlled hypertension (sitting blood pressure \> 160/95 mm Hg). 5. Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks. 6. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status. 7. Presence of hypersensitivity to Empagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions). 8. Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin…). 9. Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks. 10. Eating disorders (anorexia, bulimia) or gastrointestinal disorders. 11. Having a history of bariatric surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual diaries | 3-6 months | regulate menses cycles |
| Follicle-stimulating hormone | 3-6 months | FSH |
| Free androgen index | 3-6 months | total testosterone & sex hormone binding globulin (SHBG) |
| Transvaginal ultrasonography | 3-6 months | disappearance of PCOS |
| Fertility parameters | 3-6 months | \[luteinizing hormone (LH) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile (metabolic parameters) | 3-6 months | Total cholesterol, Low density lipoprotein (LDL), very low density lipoprotein (VLDL), high density lipoprotein (HDL), triglycerides (TG), atherogenic index I, II |
| Inflammatory indices | 3-6 months | Interleukin 6 or Toll Like receptor 2 |
| Metabolic parameters | 3-6 months | Fasting blood glucose level |
Countries
Egypt
Contacts
Primary ContactHaidy M Sami, Master
Backup ContactNoha A Hamdy, PhD
Outcome results
None listed