Clinical trial NCT00631696: Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo
Official title: Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Healthy males Human volunteers pregabalin or placebo sperm quality and quantity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 222
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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

Eligibility 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

Primary outcomes:
measure: Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS)
timeFrame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
Secondary outcomes:
measure: Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS)
timeFrame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
measure: Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26
timeFrame: Baseline, Week 26 (last observation in the Week 26 window)
measure: Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12
timeFrame: Baseline, Week 12 (last observation in the Week 12 window)
measure: Change From Baseline in Testosterone to End of Study (EOS)
timeFrame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
measure: Change From Baseline in Testosterone to Week 26
timeFrame: Baseline, Week 26 (last observation in the Week 26 window)
measure: Change From Baseline in Testosterone to Week 12
timeFrame: Baseline, Week 12 (last observation in the Week 12 window)
measure: Change From Baseline in Sperm Motility to End of Study (EOS)
timeFrame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
measure: Change From Baseline in Sperm Motility to Week 26
timeFrame: Baseline, Week 26 (last observation in the Week 26 window)
measure: Change From Baseline in Sperm Motility to Week 12
timeFrame: Baseline, Week 12 (last observation in the Week 12 window)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tarzana
country: United States
facility: Pfizer Investigational Site
state: California
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cumberland
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sikka SC, Chen C, Almas M, Dula E, Knapp LE, Hellstrom WJ. Pregabalin does not affect sperm production in healthy volunteers: a randomized, double-blind, placebo-controlled, noninferiority study. Pain Pract. 2015 Feb;15(2):150-8. doi: 10.1111/papr.12171. Epub 2014 Jan 23.