drugset
drugset / Trial / NCT05994378

To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects

NCT05994378 ↗

Phase 3 Completed 317 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multi-center, randomized, double-blind, positive drug-controlled, non-inferiority Phase III clinical trial. The study will enroll approximately 316 infertile female subjects undergoing controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.

Timeline

Start
2023-08-29
Primary completion
2025-05-02
Completion
2025-05-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ganirelix Protein / enzyme biologic 0.25 mg —
Subject SHR7280 Small molecule 200 mg Oral

Indications

female infertility