drugset / Trial / NCT05442827

A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids

NCT05442827

Phase 2/3 Unknown 357 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Phase II:To explore the optimal effective dose of SHR7280 tablets in subjects with menorrhagia with uterine fibroids as a phase III treatment dose. Phase III:To evaluate the efficacy of the selected dose of SHR7280 compared with placebo in reducing menstrual bleeding in subjects with menorrhagic uterine fibroids in phase II studies.

Timeline

Start
2022-09-10
Primary completion
2026-06-01
Completion
2026-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject SHR7280 Small molecule 300 mg
Subject SHR7280 Small molecule 400 mg