Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo
Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Pregabalin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
Official title: Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo
Study design: Other, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Safety Study
Primary outcome: Percentage of subjects with a 50% or more reduction from baseline to end of study (Week 26, or last assessment on or after Week 12 if Week 26 not done) in sperm concentration.
Secondary outcome: Change from baseline in Follicle Stimulating Hormone (FSH)Change from baseline in testosterone Change from baseline in sperm motility
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy 18 to 55 years old males
Exclusion Criteria:
- 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
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Mobile, Alabama 36607, United States; Recruiting
Pfizer Investigational Site, Phoenix, Arizona 85013, United States; Recruiting
Pfizer Investigational Site, Tarzana, California 91356, United States; Not yet recruiting
Pfizer Investigational Site, OCALA, Florida 34474, United States; Recruiting
Pfizer Investigational Site, Madisonville, Kentucky 42431, United States; Recruiting
Pfizer Investigational Site, Shreveport, Louisiana 71103, United States; Recruiting
Pfizer Investigational Site, Shrevport, Louisiana 71106, United States; Recruiting
Pfizer Investigational Site, Ann Arbor, Michigan 48109, United States; Recruiting
Pfizer Investigational Site, Ann Arbor, Michigan 48109-5330, United States; Recruiting
Pfizer Investigational Site, Minneapolis, Minnesota 55455, United States; Recruiting
Pfizer Investigational Site, Las Vegas, Nevada 89148, United States; Recruiting
Pfizer Investigational Site, Durham, North Carolina 27713, United States; Not yet recruiting
Pfizer Investigational Site, Cumberland, Rhode Island 02864, United States; Recruiting
Pfizer Investigational Site, Houston, Texas 77024, United States; Not yet recruiting
Pfizer Investigational Site, San Antonio, Texas 78229, United States; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2008
Ending date: July 2009
Last updated: October 6, 2008
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