drugset / Trial / NCT04700839

SGLT2 Inhibitors in Patients With PCOS

NCT04700839

Phase 4 Completed 68 enrolled Shanghai 10th People's Hospital
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

Drugs

EvaluationDrugModalityDoseRoute
Subject CANAGLIFLOZIN ANHYDROUS Small molecule 100 mg
Comparator Metformin Small molecule 1500 mg
Comparator Metformin Small molecule 2000 mg