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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).
Patients with polycystic ovary syndrome will be randomized to three arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin arm (control group) | Active Comparator | Patients will receive Metformin (1500 mg orally/day) for 12 weeks . |
|
| Empagliflozin arm | Active Comparator | Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks. |
|
| Linagliptin arm | Active Comparator | Patients will receive Linagliptin (10 mg orally/day) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 mg | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Fertility parameters | [luteinizing hormone (LH)](streamdown:incomplete-link) | 3-6 months |
| Follicle-stimulating hormone | FSH | 3-6 months |
| Free androgen index | total testosterone & sex hormone binding globulin (SHBG) | 3-6 months |
| Transvaginal ultrasonography | disappearance of PCOS | 3-6 months |
| Menstrual diaries | regulate menses cycles | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic parameters | Fasting blood glucose level | 3-6 months |
| Lipid profile (metabolic parameters) | Total cholesterol, Low density lipoprotein (LDL), very low density lipoprotein (VLDL), high density lipoprotein (HDL), triglycerides (TG), atherogenic index I, II |
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Inclusion Criteria:
Exclusion Criteria:
This study is for the treatment of polycystic ovary syndrome (PCOS)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haidy M Sami, Master | Contact | +201015299642 | gs-haidy.sami@alexu.edu.eg | |
| Noha A Hamdy, PhD | Contact | +201005182151 | noha.alaaeldine@alexu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hanan N Abdel Hafez, PhD | Professor of Obstetrics and Gynecology, Faculty of Medicine Mansoura University | Study Chair |
| Ahmed I ElMallah, PhD | Professor of Pharmacology and Therapeutics, Faculty of Pharmacy Alexandria University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Recruiting | Alexandria | 21521 | Egypt |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000069476 | Linagliptin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Linagliptin 10 mg | Drug | 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) |
|
|
| Metformin 1500 mg | Drug | 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) |
|
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| 3-6 months |
| Inflammatory indices | Interleukin 6 or Toll Like receptor 2 | 3-6 months |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D011799 | Quinazolines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |