Table 1.

Randomized, placebo-controlled phase II and III clinical trials investigating the efficacy of the phosphodiesterase type 5 (PDE5) inhibitor avanafil in patients with mild to severe erectile dysfunction. Treatment period in all trials listed was 12 weeks (after a 4-week nontreatment run-in period). For the clinical key data presented by Zhao et al. [2012], see the text.

Study	Drug doses evaluated	Number of patients	Improvement in SEP 2 (%) (versus placebo)	Improvement in SEP 3 (%) (versus placebo)	Successful sexual attempts (SEP 3) (%) at ≤ 15 min (versus placebo)	Improvement in IIEF-EF score (versus placebo)	Shift to normal erectile function (EF score ≥ 26) (%) (versus placebo)
Kaufmann and Dietrich [2006]	50 mg 100 mg 200 mg 300 mg	284	16.1a 19.1b 19.7b 23.6c	25.9c 30.6c 34.1c 36.3c	NE	+ 3.9b + 5.3c + 6.0c + 6.7c	NE
Zhao et al. [2012]	100 mg 200mg	200	11.3c 13.5c	28.5c 29.5c	NE	+ 5.0c + 5.3c	28.9c 22.7c
Goldstein et al. [2012b]	50 mg 100 mg 200 mg	646	10.0d 20.0e 23.0e	14.0d 30.0e 30.0e	37 40 44	+ 2.8d + 5.6e + 6.9e	9.1 28.7 32.1
Goldstein et al. [2012a] REVIVE-D Study (#TA-302)	100 mg 200 mg	390	12.0d 21.0d	14.0d 20.0d	See Goldstein et al. [2012a]	+ 2.7d + 4.1d	NE
Mulhall et al. [2012]	100 mg 200 mg	298	12.0c 21.0c	14.0c 17.0c	45 28	+ 3.3c + 5.4c	NE

^ap < 0.05; ^bp < 0.01; ^cp < 0.001; ^dp < 0.005; ^ep < 0.0001.

EF, erectile function; IIEF, International Index of Erectile Function; NE, not evaluated; SEP, Sexual Encounter Profile.