Preclinical Observations Testicular Changes
- In a 2-year rat study, an increased incidence of slight testicular tubular atrophy was observed
- Not observed in a 2-year mouse study
- The overall pattern and findings were not typical of drug-induced testicular toxicity
- No effect on sperm count, motility or male fertility in rats treated with oral bosentan at doses up to 50 times the recommended human dose