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

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NCT00631696

Last updated on August 9, 2018
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FOR MORE INFORMATION
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 Class "a" motile or screening sperm morphology white blood cell count >1 x 106 /mL on any screening visit sample

NCT00631696
Pfizer
Completed
Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo

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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.
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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Healthy
  • Drug: Pregabalin
    pregabalin 600 mg given twice a day
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
February 2012
February 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00631696
A0081104
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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1-800-718-1021

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[email protected]



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