NCT05082233

Identify Effective Doses of SHR7280 Tablets in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)

A Multicentre, Open-label, ph2 Clinical Study to Investigate the Efficacy, Safety, and Tolerance of Different Doses of Oral SHR7280 Tablets in Controlled Ovarian Hyperstimulation for Chinese Female Subjects Undergoing Assisted Reproductive Technology (ART)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicentre, open-label phase II dose-finding clinical trial that will recruit approximately 120 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). We set up three SHR7280 tablets dose groups of 300 mg BID, 200 mg BID, and 200 mg QD with 40 subjects in each group, besides, a group of 400mg bid is set as an alternative.

Conditions

• Female Subjects Undergoing COH in ART to Prevent Early Ovulation

Interventions

Type	Name	Description
DRUG	SHR7280 tablets	Treatment group A:SHR7280 tablets ; 300mg BID； Treatment group B:SHR7280 tablets ; 200mg BID； Treatment group C:SHR7280 tablets ; 200mg QD； Treatment group D:SHR7280 tablets ; 400mg BID；

Timeline

• Start date: 2022-03-06
• Primary completion: 2023-08-03
• Completion: 2023-08-03
• First posted: 2021-10-18
• Last updated: 2024-02-20

Locations

1 site across 1 country: China