Clinical Studies Avanafil
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STENDRA was evaluated in 3 randomized, double-blind, placebo-controlled, parallel group trials of up to 3 months in duration. In these 3 trials, STENDRA was taken as needed at doses of 50 mg, 100 mg, and 200 mg. Patients were instructed to take 1 dose of study drug approximately 30 minutes prior to initiation of sexual activity. Food and alcohol intake was not restricted.
In addition, a subset of patients from 2 of these trials were enrolled into an open-label extension trial. In the open-label extension trial, all eligible patients were initially assigned to avanafil 100 mg. At any point during the trial, patients could request to have their dose of avanafil increased to 200 mg or decreased to 50 mg based on their individual response to treatment.
The 3 primary outcome measures were the erectile function domain of the International Index of Erectile Function (IIEF) and Questions 2 and 3 from Sexual Encounter Profile (SEP). The IIEF is a 4-week recall questionnaire that was administered at baseline
and at 4-week intervals during treatment. The IIEF erectile function domain has a 30-point total score, where the higher scores reflect better erectile function. The SEP included diary-based measures of erectile function. Patients recorded information regarding each sexual attempt made throughout the trial. Question 2 of the SEP asks “Were you able to insert your penis into your partner’s vagina?” Question 3 of the SEP asks “Did your erection last long enough for you to have successful intercourse?”
Results are shown from the two, Phase 3, randomized, double-blind, placebo-controlled, parallel studies, one in the general ED population (Study 1) and the other in the diabetic population with ED (Study 2).
Results in the General ED Population (Study 1):
STENDRA was evaluated in 646 men with ED of various etiologies (organic, psychogenic, mixed). The mean age was 55.7 years (range 23 to 88 years). The population was 85.6% White, 13.2% Black,0.9% Asian, and 0.3% of other races. The mean duration of ED was approximately 6.5 years. STENDRA at doses of 50 mg, 100 mg, and 200 mg demonstrated statistically significant improvement in all 3 primary efficacy variables relative to placebo (see Table 6).
Table 6: Mean Change From Baseline for Primary Efficacy Variables in General ED Population (Study 1)
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Placebo (N=155) |
STENDRA 50 mg (N=154) |
STENDRA 100 mg (N=157) |
STENDRA 200 mg (N=156) |
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IIEF EF Domain Score |
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Endpoint |
15.3 |
18.1 |
20.9 |
22.2 |
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Change from baseline† |
2.9 |
5.4 |
8.3 |
9.5 |
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p-value* |
0.0014 |
<0.0001 |
<0.0001 |
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Vaginal Penetration (SEP2) |
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Endpoint |
53.8% |
64.3% |
73.9% |
77.3% |
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Change from baseline† |
7.1% |
18.2% |
27.2% |
29.8% |
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p-value* |
- |
0.0009 |
<0.0001 |
<0.0001 |
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Successful Intercourse (SEP3) |
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Endpoint |
27.0% |
41.3% |
57.1% |
57.0% |
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Change from baseline† |
14.1% |
27.8% |
43.4% |
44.2% |
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p-value* |
- |
0.0002 |
<0.0001 |
<0.0001 |
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† Least-square estimate from ANCOVA model * comparison to placebo for change from baseline |
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2 diabetes mellitus in a randomized, double-blind, parallel, placebo-controlled fixed dose trial of 3 months in duration. The mean age was 58 years (range 30 to 78 years). The population was 80.5% White, 17.2% Black, 1.5% Asian, and 0.8% of other races. The mean duration of ED was approximately 6 years. In this trial, STENDRA at doses of 100 mg and 200 mg demonstrated statistically significant improvement in all 3 primary efficacy variables as measured by the erectile function domain of the IIEF questionnaire; SEP2 and SEP3 (see Table 7).
Table 7: Mean Change From Baseline for Primary Efficacy Variables in ED Population with Diabetes Mellitus (Study 2)
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Placebo (N=127) |
STENDRA 100 mg (N=126) |
STENDRA 200 mg (N=126) |
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IIEF EF Domain Score |
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Endpoint |
13.2 |
15.8 |
17.3 |
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Change from baseline† |
1.8 |
4.5 |
5.4 |
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p-value* |
- |
0.0017 |
<0.0001 |
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Vaginal Penetration (SEP2) |
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Endpoint |
42.0% |
54.0% |
63.5% |
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Change from baseline† |
7.5% |
21.5% |
25.9% |
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p-value* |
- |
0.0004 |
<0.0001 |
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Successful Intercourse (SEP3) |
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Endpoint |
20.5% |
34.4% |
40.0% |
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Change from baseline† |
13.6% |
28.7% |
34.0% |
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p-value* |
- |
<0.0001 |
<0.0001 |
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† least-square estimate from ANCOVA model * comparison to placebo for change from baseline |
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