Status:
UNKNOWN
Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome
Lead Sponsor:
Alexandria University
Conditions:
Polycystic Ovary Syndrome (PCOS)
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
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 hor...
Eligibility Criteria
Inclusion
- Women diagnosed with PCOS according to National Institute of Health criteria.
- Age: \>18 \<40 years.
- Infertile women (primary or secondary infertility).
Exclusion
- Patients with history of diabetes mellitus (Type 1 or 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.
- Significantly elevated triglyceride levels (fasting triglyceride \> 400 mg/dL)
- Untreated or poorly controlled hypertension (sitting blood pressure \> 160/95 mm Hg).
- 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.
- 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.
- Presence of hypersensitivity to Empagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).
- Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin…).
- Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.
- Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
- Having a history of bariatric surgery.
Key Trial Info
Start Date :
December 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05200793
Start Date
December 7 2021
End Date
September 1 2022
Last Update
January 21 2022
Active Locations (1)
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1
Alexandria University
Alexandria, Egypt, 21521