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ACTIVE NOT RECRUITING
NCT07236476
PHASE2

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

Sponsor: Luye Pharma Group Ltd.

View on ClinicalTrials.gov

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.

Official title: A Multicentre, Open-label, Dose-finding, Phase 2 Study to Investigate the Efficacy, and Safety of Different Doses of LY01021 in Controlled Ovarian Hyperstimulation(COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)

Key Details

Gender

FEMALE

Age Range

20 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-10-09

Completion Date

2025-12-31

Last Updated

2025-11-19

Healthy Volunteers

No

Interventions

DRUG

LY01021

LY01021 should be taken orally once a day.

Locations (1)

Peking University Third Hospital

Beijing, China