Conditions: Healthy
Keywords: Healthy males Human volunteers pregabalin or placebo sperm quality and quantity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 222
Healthy volunteers: yes

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

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: pregabalin 600 mg given twice a day intervention 2: Placebo

Protocol document: