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

Last updated: January 14, 2022
Sponsor: Alexandria University
Overall Status: Active - Recruiting

Phase

4

Condition

Reproductive Health

Female Hormonal Deficiencies/abnormalities

Polycystic Ovarian Syndrome

Treatment

N/A

Clinical Study ID

NCT05200793
0201566
  • Ages 18-40
  • Female

Study 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).

Eligibility Criteria

Inclusion

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

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 endocrineor 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 orweight loss medications (prescription or OTC) and medications known to exacerbateglucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids,anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that actperipherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for atleast 4 weeks.
  6. Patients at risk for volume depletion due to co-existing conditions or concomitantmedications, such as loop diuretics should have careful monitoring of their volumestatus.
  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) receptoragonists, 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

Total Participants: 75
Study Start date:
December 07, 2021
Estimated Completion Date:
September 01, 2022

Study 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

Connect with a study center

  • Alexandria University

    Alexandria, 21521
    Egypt

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.