drugset / Trial / NCT04700839
SGLT2 Inhibitors in Patients With PCOS
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2020-05-01
- Primary completion
- 2021-04-28
- Completion
- 2021-04-30
Publications
- Results Javed 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.
- Yan 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CANAGLIFLOZIN ANHYDROUS | Small molecule | 100 mg | — |
| Comparator | Metformin | Small molecule | 1500 mg | — |
| Comparator | Metformin | Small molecule | 2000 mg | — |