Table 3.

Drug-Related Sexual Adverse Events

	Pivotal	PLESS
	% Dutasteride Patients	% Finasteride Patients
	(% Placebo Patients)	(% Placebo Patients)
Impotence	6.0 (3.0)	8.1 (3.7)
Decreased libido	3.7 (1.9)	6.4 (3.4)
Ejaculatory disorder	1.8 (0.7)	3.7 (0.8)
Gynaecomastia*	1.3 (0.5)	0.9 (0.2)

Percentage of patients who withdrew due to sexual adverse events or gynaecomastia over 4 years of dutasteride treatment is low.

^*Includes breast enlargement and breast/nipple tenderness (reported separately in PLESS). PLESS, Proscar Long-Term Efficacy and Safety Study. Data from Roehrborn CG et al.⁴ and McConnell JD et al.⁵