Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo

Phase 4 Completed 222 enrolled Viatris Inc.

RandomizedParallel-groupDouble-blindOther

Summary

This study is being performed as a Phase IV FDA commitment study and is being powered adequately to assess changes in sperm concentration, FSH and testosterone in healthy male subjects treated with pregabalin as compared to placebo, in addition to confirming lack of effects on sperm motility.

Timeline

Start: 2008-02
Primary completion: 2012-02
Completion: 2012-02

Publications

Sikka SC, Chen C, Almas M, Dula E, Knapp LE, Hellstrom WJ. Pregabalin does not affect sperm production in healthy volunteers: a randomized, double-blind, placebo-controlled, noninferiority study. Pain Pract. 2015 Feb;15(2):150-8. doi: 10.1111/papr.12171. Epub 2014 Jan 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	600 mg	—

Indications

No indication recorded.