Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome

  • STATUS
    Recruiting
  • days left to enroll
    64
  • participants needed
    75
  • sponsor
    Alexandria University
Updated on 25 March 2022
metformin
infertility

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

Details
Condition Polycystic Ovary Syndrome (PCOS)
Treatment Empagliflozin 25 mg, Linagliptin 10 mg, Metformin 1500 mg
Clinical Study IdentifierNCT05200793
SponsorAlexandria University
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women diagnosed with PCOS according to National Institute of Health criteria
Age: >18 <40 years
Infertile women (primary or secondary infertility)

Exclusion Criteria

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
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