Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)

Phase 2 Active not recruiting 90 enrolled Luye Pharma Group Ltd.

NaSequentialOpen-labelTreatment

Summary

This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). Three LY01021 dose groups of 40 mg QD, 30 mg QD, and 20 mg QD will be included, with not exceed 45 subjects in each group to investigate the efficacy and safety.

Timeline

Start: 2024-10-09
Primary completion: 2025-12-31
Completion: 2025-12-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LY01021	Unknown	20 mg	Oral
Subject	LY01021	Unknown	30 mg	Oral
Subject	LY01021	Unknown	40 mg	Oral

Indications

No indication recorded.