NCT00631696

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

Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 4 FDA commitment study. The purpose of the study is to evaluate the effects of pregabalin as compared to placebo on sperm concentration in healthy male subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pregabalin	pregabalin 600 mg given twice a day
DRUG	Placebo	Placebo

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2008-03-10
• Last updated: 2021-01-26
• Results posted: 2012-10-24

Locations

13 sites across 1 country: United States