Table 2.

Primary and secondary efficacy results

	Placebo (n = 31)			Tadalafil 20 mg (n = 101)
	Baseline	End point	Change (mean ± SE)	Baseline	End point	Change (mean ± SE)	p-value
Primary end points
IIEF EF domain	14.5	16.8	2.3 ± 1.6	14.5	23.8	9.3 ± 0.8	<0.001
SEP2 (successful penetration) (mean per patient % yes)	55.6	51.0	−4.6 ± 8.1	44.4	78.9	34.5 ± 4.1	<0.001
SEP3 (successful intercourse) (mean per patient % yes)	17.9	34.7	16.8 ± 7.8	14.0	66.1	52.2 ± 3.8	<0.001
Secondary end points
IIEF questions
IIEF Q3. Penetration ability	2.7	2.9	0.2 ± 0.3	2.6	4.1	1.5 ± 0.2	<0.001
IIEF Q4. Maintenance ability	2.0	2.8	0.8 ± 0.3	1.9	3.9	2.0 ± 0.2	<0.001
IIEF domains
Intercourse satisfaction	7.1	9.4	2.3 ± 0.7	6.4	11.2	4.8 ± 0.3	0.001
Overall satisfaction	4.6	5.7	1.1 ± 0.6	4.0	7.6	3.6 ± 0.3	<0.001
Patient SEP questions (mean per patient % yes)
SEP4 (satisfied with hardness)	8.7	30.3	21.7 ± 6.8	8.6	61.4	52.8 ± 3.8	<0.001
SEP5 (overall satisfaction)	8.7	29.2	20.5 ± 6.8	8.1	57.3	49.1 ± 3.9	<0.001
GAQ (% of patients with ‘yes’ response)
GAQ1. Improved erections		41.9			81.2		<0.001
GAQ2. Improved sexual activity		41.9			76.2		<0.001

IIEF, International Index of Erectile Function; SEP, Sexual Encounter Profile; GAQ, Global Assessment Question.