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Study on the Safety and Pharmacokinetics of LM001 and Gonal-F® in Healthy Women

Infertility, Female Clinical Trial

Official title:
A Randomized, Open-label, Two-Period, Two-Crossover Study to Compare the Safety and Pharmacokinetics of Recombinant Human Follicle Stimulating Hormone Injection (LM001) and Gonal-F® in Healthy Female Volunteers

Clinical Trial Summary

Brief Summary: LM001 is a recombinant human Follicle Stimulating Hormone (r-hFSH) Injection, which is proposed for Assisted Reproductive Technology (ART). This is a randomized, open-label, two-period, two-crossover study to evaluate the safety and pharmacokinetics of recombinant human follicle stimulating hormone injection (LM001), compared with Gonal-F®, both given subcutaneously.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03535103
Study type Interventional
Source Alphamab Jilin Co., Ltd.
Contact Yanhua Ding, M.D.
Phone 86-0431-88782168
Email dingyanhua2003@126.com
Status Not yet recruiting
Phase Phase 1
Start date June 1, 2018
Completion date December 31, 2019
View Details
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