Clinical trial · Interventional
SGLT2 Inhibitors in Patients With PCOS
The Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome: A Randomized, Open Label Trial
- 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)
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Metformin has been clarified as an option in patients with PCOS. However, the clinical responses to metformin are limited and different. Sodium glucose co-transporter 2 (SGLT2) inhibitors are novel drugs for the treatment of type 2 diabetes, with weight loss, reducing insulin resistance and cardiovascular benefits. Limited data is available on the efficacy of SGLT2 inhibitors in patients 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 |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| SGLT2 inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SGLT2 inhibitors group
- description
- Intervention with SGLT2 inhibitors (100mg/d) for 3 months
- interventionNames
- Drug: SGLT2 inhibitors
- type
- ACTIVE_COMPARATOR
- label
- Metformin group
- description
- Intervention with metformin (1500-2000mg/d) for 3 months
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- HOMA-IR
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion criteria: * Fmale aged 18- 45; * Meet Rotterdam criteria; * Insulin Rsistance Exclusion Criteria: * Women who are pregnant or have a pregnancy plan within six months; ·Congenital adrenocortical hyperplasia; * Hyperprolactinemia; * Hyperthyroidism or hypothyroidism; * Abnormal liver function (≥ 3 times of the upper limit of normal range); * Abnormal renal function (GFR\<60ml/min/1.73m2); * Adrenal or ovarian tumors secreting androgens; * Used contraceptives, metformin, GLP-1RA, SGLT2I, pioglitazone and contraceptives in the last 3 month.
References
Publications (2)
- 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
- DERIVEDYan Q, Cai M, Wang N, Wu W, Zhang H, Zhu Y, Luo J, Zhang M, Li J. Circulating Profiles of the Bile Acid Metabolomics in Patients With Polycystic Ovary Syndrome Treated With Metformin or Canagliflozin. Pharmacotherapy. 2026 Feb;46(2):e70092. doi: 10.1002/phar.70092. Epub 2025 Dec 16. PMID 41401816