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

NCT ID: NCT00631696

Last Updated: 2021-01-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-02-29

Brief Summary

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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

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

pregabalin 600 mg given twice a day

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Pregabalin

pregabalin 600 mg given twice a day

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Mobile, Alabama, United States

Site Status

Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Tarzana, California, United States

Site Status

Pfizer Investigational Site

Ocala, Florida, United States

Site Status

Pfizer Investigational Site

Madisonville, Kentucky, United States

Site Status

Pfizer Investigational Site

Shreveport, Louisiana, United States

Site Status

Pfizer Investigational Site

Shreveport, Louisiana, United States

Site Status

Pfizer Investigational Site

Ann Arbor, Michigan, United States

Site Status

Pfizer Investigational Site

Minneapolis, Minnesota, United States

Site Status

Pfizer Investigational Site

Las Vegas, Nevada, United States

Site Status

Pfizer Investigational Site

Durham, North Carolina, United States

Site Status

Pfizer Investigational Site

Cumberland, Rhode Island, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24450301 (View on PubMed)

Related Links

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Other Identifiers

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A0081104

Identifier Type: -

Identifier Source: org_study_id

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