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

Completed · Phase 4 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00631696

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

222

Starts

2008-02-01

Expected to finish

2012-02-01

Last updated by the study team

2021-01-26

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy 18 to 55 years old males

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Mobile, Alabama, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tarzana, California, United States
• Pfizer Investigational Site — Ocala, Florida, United States
• Pfizer Investigational Site — Madisonville, Kentucky, United States
• Pfizer Investigational Site — Shreveport, Louisiana, United States
• Pfizer Investigational Site — Shreveport, Louisiana, United States
• Pfizer Investigational Site — Ann Arbor, Michigan, United States
• Pfizer Investigational Site — Minneapolis, Minnesota, United States
• Pfizer Investigational Site — Las Vegas, Nevada, United States
• Pfizer Investigational Site — Durham, North Carolina, United States
• Pfizer Investigational Site — Cumberland, Rhode Island, United States
• Pfizer Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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