Clinical trial · Interventional
Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome
A Comparative Clinical Study Evaluating the Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome in Egyptian Women
NCT05200793CI-TRIAL-00056077unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Empagliflozin 25 mg | Drug | — | UNRESOLVED |
| Linagliptin 10 mg | Drug | — | UNRESOLVED |
| Metformin 1500 mg | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Metformin arm (control group)
- description
- Patients will receive Metformin (1500 mg orally/day) for 12 weeks .
- interventionNames
- Drug: Metformin 1500 mg
- type
- ACTIVE_COMPARATOR
- label
- Empagliflozin arm
- description
- Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks.
- interventionNames
- Drug: Empagliflozin 25 mg
- type
- ACTIVE_COMPARATOR
- label
- Linagliptin arm
- description
- Patients will receive Linagliptin (10 mg orally/day) for 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.