drugset / Trial / NCT04491682

Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

NCT04491682

Phase 2/3 Completed 36 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

To see if megestrol acetate plus rosuvastatin will be superior to reversing the endometrial lesion to a normal endometrium than megestrol acetate alone in patients with atypical endometrial hyperplasia (AEH). Considering the large sample size in RCT, we used Simon two-stage design.

Timeline

Start
2020-09-01
Primary completion
2022-06-20
Completion
2022-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Megestrol Acetate Other / unclassified 160 mg Oral
Subject Rosuvastatin Small molecule 10 mg Oral