At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 222 enrolled
Drug / intervention
Pregabalin +1 moredrug
Likely dose
Pregabalin 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Mar 10, 2008·Updated Jan 26, 2021
In Brief
A Phase 4 clinical trial evaluating Pregabalin and Placebo for Healthy. Completed, enrolled 222 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedMar 2008
Primary CompletionFeb 2012
TodayJul 2026
First PostedMar 10, 2008
Enrollment StartFeb 1, 2008
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.3 years ago
Interventions
Pregabalindrug
pregabalin 600 mg given twice a day
Placebodrug
Placebo