NCT05442827

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

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Phase II/III Clinical Study to Explore the Optimal Therapeutic Dose of SHR7280 Tablets and the Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia for Uterine Fibroids

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 357 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroids With Menorrhagia

Interventions

Type	Name	Description
DRUG	SHR7280 tablets	SHR7280 tablets 300mg for 12 weeks
DRUG	SHR7280 tablets	SHR7280 tablets 400mg for 12 weeks
DRUG	PlaceboSHR7280 tablets blank preparation	Placebo group: SHR7280 tablets blank preparation for 12 weeks

Timeline

• Start date: 2022-09-10
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-07-05
• Last updated: 2024-01-24

Locations

1 site across 1 country: China