Status:
COMPLETED
Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE4
Brief 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 pr...
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
Eligibility Criteria
Inclusion
- Healthy 18 to 55 years old males
Exclusion
- Screening sperm count \<20 x 106/mL; screening sperm motility \<50% motile (a+b) or \<25% Class "a" motile or screening sperm morphology \<30% normal or semen volume \<1.5 mL or white blood cell count \>1 x 106 /mL on any screening visit sample
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT00631696
Start Date
February 1 2008
End Date
February 1 2012
Last Update
January 26 2021
Active Locations (13)
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1
Pfizer Investigational Site
Mobile, Alabama, United States, 36607
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
3
Pfizer Investigational Site
Tarzana, California, United States, 91356
4
Pfizer Investigational Site
Ocala, Florida, United States, 34474