NCT03662958

Comparison of a Novel Leuprolide With Market Leuprolide

Evaluation of the Testosterone Suppressive Effect in Healthy Male Volunteers of a Novel Leuprolide Acetate 3.75mg Depot (Lutrate) VS Market Reference Leuprolide Acetate 3.75mg Depot (Enantone)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a single dose, randomized, single blind, parallel group study to evaluate the testosterone suppressive effect in healthy male volunteers of a novel leuprolide acetate 3.75mg depot vs market reference leuprolide acetate 3.75mg depot. The safety, tolerability and the pharmacokinetic properties of the investigational drug and the control drug will also be assessed.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Lutrate	a novel leuprolide acetate 3.75mg depot
DRUG	Enantone	market reference leuprolide acetate 3.75 mg depot

Timeline

• Start date: 2018-08-01
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2018-09-10
• Last updated: 2018-09-10

Locations

1 site across 1 country: China