Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-04-15 @ 10:54 AM
Study NCT ID:
NCT05442827
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2022-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids
Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: