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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
222
pregabalin 600 mg given twice a day
Placebo
Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tarzana, California, United States
Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS)
Baseline is the average of sperm concentrations from semen samples collected on or before Study Day 1. End of study is average of sperm concentrations from semen samples collected at end of washout period (Week 26) following 12 weeks of double-blind treatment. Mean sperm concentration (MSC) of a visit is average of the 2 sperm concentration samples collected at that visit. If sperm concentration was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead. Confidence intervals (CI) based on exact distribution.
Time frame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS)
FSH minimum normal range 1.4 International units per liter (IU/L) to maximum normal range 18.1 IU/L. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.
Time frame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26
FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.
Time frame: Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12
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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
...and 3 more locations
FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.
Time frame: Baseline, Week 12 (last observation in the Week 12 window)
Change From Baseline in Testosterone to End of Study (EOS)
End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.
Time frame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
Change From Baseline in Testosterone to Week 26
Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.
Time frame: Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Testosterone to Week 12
Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.
Time frame: Baseline, Week 12 (last observation in the Week 12 window)
Change From Baseline in Sperm Motility to End of Study (EOS)
Mean sperm motility (percent motility representing grade a+b \[a=sperm with progressive, straight-line motility; b=non-linear motility\]) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.
Time frame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
Change From Baseline in Sperm Motility to Week 26
Mean sperm motility (percent motility representing grade a+b) was the average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 26 was average of the last 2 values within window of 134 to 252 days from Study Day 1 and at least 1 of the 2 values was non-missing. If only 1 assessment date within the stated window, Week 26 was the value of that single assessment. If all values within window were missing, the records were not to be used for Week 26 analysis.
Time frame: Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Sperm Motility to Week 12
Mean sperm motility (percent motility representing grade a+b) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 12 was average of last 2 values within window of 2 to 133 days from Study Day 1 and at least 1 of the 2 values was non-missing. If there was only 1 assessment date within the stated window, then Week 12 was the value of that single assessment. If all the values within the window were missing, then the records were not to be used for Week 12 analysis.
Time frame: Baseline, Week 12 (last observation in the Week 12 window)