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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05200793
Other study ID # 0201566
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 7, 2021
Est. completion date September 1, 2022

Study information

Verified date January 2022
Source Alexandria University
Contact Haidy M Sami, Master
Phone +201015299642
Email gs-haidy.sami@alexu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date September 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Intervention

Drug:
Empagliflozin 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)
Linagliptin 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)
Metformin 1500 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)

Locations

Country Name City State
Egypt Alexandria University Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fertility parameters [luteinizing hormone (LH) 3-6 months
Primary Follicle-stimulating hormone FSH 3-6 months
Primary Free androgen index total testosterone & sex hormone binding globulin (SHBG) 3-6 months
Primary Transvaginal ultrasonography disappearance of PCOS 3-6 months
Primary Menstrual diaries regulate menses cycles 3-6 months
Secondary Metabolic parameters Fasting blood glucose level 3-6 months
Secondary 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 3-6 months
Secondary Inflammatory indices Interleukin 6 or Toll Like receptor 2 3-6 months
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