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

Viatris

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631696

A0081104

Details and patient eligibility

About

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.

Full 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

Enrollment: 222 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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222 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Pregabalin

2

Placebo Comparator group

Treatment:

Drug: Placebo