Table 2.

Percentage of Patients Reporting the Most Common Drug-Related Side Effects in the Placebo-Controlled Trials and Open-Label Extension

	Months
	0–6	7–12	13–18	19–24	24–36	36–48
Patients, n
Dutasteride	2167	1901	1725	1605	2340	1041
Placebo	2158	1922	1714	1555	No patients	No patients
Decreased libido
Dutasteride	3.0%*	0.7%	0.3%	0.3%	0.4%	0.1%
Placebo	1.4%	0.6%	0.2%	0.0%	-	-
Gynecomastia
Dutasteride	0.5%*	0.8%*	1.1%*	0.6%*	0.9%	0.7%
Placebo	0.2%	0.3%	0.3%	0.1%	-	-
Impotence
Dutasteride	4.7%*	1.4%	1.0%	0.8%	1.4%	0.4%
Placebo	1.7%	1.5%	0.5%	0.9%	-	-
Ejaculation disorder
Dutasteride	1.4%*	0.5%	0.5%	0.1%	0.3%	0.1%
Placebo	0.5%	0.3%	0.1%	0.0%	-	-

^*P < .05, dutasteride vs placebo.

Data from Roehrborn et al¹³ and Andriole et al.¹⁸