drugset / Trial / NCT05442827
A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SHR7280 | Small molecule | 300 mg | — |
| Subject | SHR7280 | Small molecule | 400 mg | — |