Pregabalin does not affect male reproductive function

August 8, 2012

Pregabalin (Lyrica) capsules do not affect reproductive function in healthy males when compared with placebo, according to results from a study conducted as a post-approval commitment required by the FDA.

Pregabalin (Lyrica) capsules do not affect reproductive function in healthy males when compared with placebo, according to results from a study conducted as a post-approval commitment required by the FDA.

The objective of the phase IV, multicenter, double-blind, randomized, placebo-controlled study was to evaluate the effects of pregabalin compared with placebo on sperm concentration in healthy males. A total of 222 subjects were randomized at 12 study centers in the U.S. One hundred and eleven subjects received pregabalin and 109 subjects received placebo for 12 weeks followed by a 3-month washout period.

Patients in the pregabalin arm received 600 mg/day (300 mg twice daily) for 10 weeks after a 2-week titration that started at 100 mg/day (50 mg twice daily). Subjects who could not tolerate 600 mg/day had their dosage reduced to 450 mg/day (225 mg twice daily) and those who were unable to tolerate 450 mg/day were dropped from the study.

The primary endpoint of the study, the proportion of subjects with a 50% or more reduction in sperm concentration from baseline to end of study (week 26) last observation, was met, according to Pfizer Inc.

Pregabalin is indicated for the treatment of fibromyalgia, diabetic nerve pain, pain after shingles, neuropathic pain associated with spinal cord injury, and partial-onset seizures.

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