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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00631696
First received: February 15, 2008
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Pregabalin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS) [ 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) ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS) [ 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 26 (last observation in the Week 26 window) ] [ Designated as safety issue: No ]
    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 Follicle Stimulating Hormone (FSH) to Week 12 [ Time Frame: Baseline, Week 12 (last observation in the Week 12 window) ] [ Designated as safety issue: No ]
    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 End of Study (EOS) [ 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 26 (last observation in the Week 26 window) ] [ Designated as safety issue: No ]
    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 Week 12 [ Time Frame: Baseline, Week 12 (last observation in the Week 12 window) ] [ Designated as safety issue: No ]
    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 End of Study (EOS) [ 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) ] [ Designated as safety issue: No ]
    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 Sperm Motility to Week 26 [ Time Frame: Baseline, Week 26 (last observation in the Week 26 window) ] [ Designated as safety issue: No ]
    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 Sperm Motility to Week 12 [ Time Frame: Baseline, Week 12 (last observation in the Week 12 window) ] [ Designated as safety issue: No ]
    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.


Enrollment: 222
Study Start Date: February 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pregabalin
pregabalin 600 mg given twice a day
Placebo Comparator: 2 Drug: Placebo
Placebo

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631696

Locations
United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36607
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
United States, California
Pfizer Investigational Site
Tarzana, California, United States, 91356
United States, Florida
Pfizer Investigational Site
Ocala, Florida, United States, 34474
United States, Kentucky
Pfizer Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71103
Pfizer Investigational Site
Shrevport, Louisiana, United States, 71106
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89148
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27713
United States, Rhode Island
Pfizer Investigational Site
Cumberland, Rhode Island, United States, 02864
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00631696     History of Changes
Other Study ID Numbers: A0081104
Study First Received: February 15, 2008
Results First Received: September 24, 2012
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Healthy males Human volunteers pregabalin or placebo sperm quality and quantity

Additional relevant MeSH terms:
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 22, 2014