Clinical trial · Interventional
Empagliflozin vs Metformin in PCOS
The Effect of Empagliflozin Versus Metformin on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome (PCOS) - a Randomised Open-label Parallel Study.
- 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)
This a randomised open-label parallel study involving women with polycystic ovary syndrome (PCOS). The patients will be randomised either to metformin 1500mg or empagliflozin 25mg daily for three months. The aim of the study is to examine the effect of empagliflozin on hormonal, metabolic and cardiovascular risk markers and quality of life in women with 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 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Empagliflozin | Drug | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Empagliflozin group
- description
- Each participant will receive empagliflozin 25mg daily for 3 months
- interventionNames
- Drug: Empagliflozin
- type
- ACTIVE_COMPARATOR
- label
- Metformin group
- description
- Each participant will receive metformin 1500mg daily for 3 months
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Endothelial function as measured by RHI (reactive hyperaemia index).
- timeFrame
- Three months treatment with either empagliflozin 25mg or metformin 1500mg daily
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria. 2. Presence of both irregular periods and biochemical hyperandrogenaemia 3. Body mass index ≥25 4. Negative pregnancy test during screening visit and agree to use barrier contraception during the study period. Exclusion Criteria: 1. Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease and androgen-secreting tumours will be excluded by appropriate tests. 2. Confirmed diagnosis of diabetes or pre-diabetes. 3. Ongoing, inadequately controlled thyroid disorder (subjects on thyroid hormone replacement therapy must be on stable dose for at least 3 months before screening day) 4. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinoma). 5. History or plan of any form of gastrointestinal tract surgery. 6. History of pancreatitis (Acute or Chronic). 7. Any disorder which in the opinion of the investigator might jeopardize subject's safety. 8. Subjects who are on any of the following medications within 3 months of recruitment: * Metformin or other insulin-sensitizing medications (e.g., pioglitazone ) * Hormonal contraceptives (e.g., birth control pills, hormone-releasing implants, etc.) * Anti-androgens (e.g., spironolactone, flutamide, finasteride, etc.) * Clomiphene citrate or estrogen modulators such as letrozole * GnRH modulators such as leuprolide * Minoxidil 9. Female who is pregnant, breast feeding or intended to become pregnant or of child bearing potential not using adequate contraceptive methods. 10. eGFR\<60 11. Hypersensitivity to lactose 12. Severe hepatic impairment (ALT \>3 times ULN) 13. Women with history of recurrent urinary tract infections. 14. Haematocrit above the upper limit of normal range. 15. Have been involved in another medicinal trial (CTIMP) within the past four weeks. 16. Known hypersensitivity to the Investigational Medicinal Products or any of their excipients.
References
Publications (1)
- RESULTJaved Z, Papageorgiou M, Deshmukh H, Rigby AS, Qamar U, Abbas J, Khan AY, Kilpatrick ES, Atkin SL, Sathyapalan T. Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: A randomized controlled study. Clin Endocrinol (Oxf). 2019 Jun;90(6):805-813. doi: 10.1111/cen.13968. Epub 2019 Apr 2. PMID 30866088