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/AClinical Study ID
NCT05200793
0201566
Ages 18-40 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women diagnosed with PCOS according to National Institute of Health criteria.
- Age: >18 <40 years.
- Infertile women (primary or secondary infertility).
Exclusion
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 endocrineor 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 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.
- Patients at risk for volume depletion due to co-existing conditions or concomitantmedications, such as loop diuretics should have careful monitoring of their volumestatus.
- 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) receptoragonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.
- Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
- 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
Connect with a study center
Alexandria University
Alexandria, 21521
EgyptActive - Recruiting
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