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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT00631696
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-10
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-09
• Results First Submitted: 2012-09-24
• Results First Submitted QC: 2012-09-24
• Results First Posted: 2012-10-24
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS)	Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Sperm Motility to Week 26	Baseline, Week 26 (last observation in the Week 26 window)	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.
Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS)	Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)	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.
Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26	Baseline, Week 26 (last observation in the Week 26 window)	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.
Change From Baseline in Testosterone to End of Study (EOS)	Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)	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.
Change From Baseline in Testosterone to Week 26	Baseline, Week 26 (last observation in the Week 26 window)	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.
Change From Baseline in Sperm Motility to End of Study (EOS)	Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)	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.
Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12	Baseline, Week 12 (last observation in the Week 12 window)	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.
Change From Baseline in Testosterone to Week 12	Baseline, Week 12 (last observation in the Week 12 window)	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.
Change From Baseline in Sperm Motility to Week 12	Baseline, Week 12 (last observation in the Week 12 window)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 San Antonio, Texas, United States