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
1 other identifier
interventional
222
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 healthy
Started Feb 2008
Longer than P75 for phase_4 healthy
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
March 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
October 24, 2012
CompletedJanuary 26, 2021
September 1, 2012
4 years
February 15, 2008
September 24, 2012
January 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS)
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
Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12
Baseline, Week 12 (last observation in the Week 12 window)
Change From Baseline in Testosterone to End of Study (EOS)
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
Baseline, Week 26 (last observation in the Week 26 window)
- +4 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy 18 to 55 years old males
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Pfizer Investigational Site
Mobile, Alabama, 36607, United States
Pfizer Investigational Site
Phoenix, Arizona, 85013, United States
Pfizer Investigational Site
Tarzana, California, 91356, United States
Pfizer Investigational Site
Ocala, Florida, 34474, United States
Pfizer Investigational Site
Madisonville, Kentucky, 42431, United States
Pfizer Investigational Site
Shreveport, Louisiana, 71103, United States
Pfizer Investigational Site
Shreveport, Louisiana, 71106, United States
Pfizer Investigational Site
Ann Arbor, Michigan, 48109, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55455, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89148, United States
Pfizer Investigational Site
Durham, North Carolina, 27713, United States
Pfizer Investigational Site
Cumberland, Rhode Island, 02864, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 24450301DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2008
First Posted
March 10, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
January 26, 2021
Results First Posted
October 24, 2012
Record last verified: 2012-09