drugset / Trial / NCT03662958

Comparison of a Novel Leuprolide With Market Leuprolide

NCT03662958

Unknown 48 enrolled Lee's Pharmaceutical Limited
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2018-08-01
Primary completion
2018-10
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Leuprolide Other / unclassified 3.75 mg

Indications