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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

Page last updated: November 03, 2008

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