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

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NCT00631696

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Study Location
Pfizer Investigational Site
Mobile, Alabama, 36607, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy 18 to 55 years old males

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo
Official Title  ICMJE Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Pregabalin
    pregabalin 600 mg given twice a day
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2011)		222
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2008)		150
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00631696
Other Study ID Numbers  ICMJE A0081104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP