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

Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Pregabalin

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 Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36607
      • Pfizer Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Pfizer Investigational Site
  • California
    • Tarzana, California, United States, 91356
      • Pfizer Investigational Site
  • Florida
    • Ocala, Florida, United States, 34474
      • Pfizer Investigational Site
  • Kentucky
    • Madisonville, Kentucky, United States, 42431
      • Pfizer Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Pfizer Investigational Site
    • Shreveport, Louisiana, United States, 71106
      • Pfizer Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Pfizer Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Pfizer Investigational Site
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Pfizer Investigational Site
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Pfizer Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Pregabalin; pregabalin 600 mg given twice a day
Placebo Comparator: 2	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12	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.	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.	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.	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.	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.	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.	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.	Baseline, Week 12 (last observation in the Week 12 window)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 15, 2008
• First Submitted That Met QC Criteria: March 7, 2008
• First Posted (Estimate): March 10, 2008

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Healthy males Human volunteers pregabalin or placebo sperm quality and quantity
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081104