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Clinical Studies Avanafil

was evaluated in 3 randomized, double-blind, placebo-controlled, parallel group trials up to a couple of months in duration. During 3 trials, was taken as needed at doses of 50 mg, 100 mg, and 200 mg. Patients were instructed to look at 1 dose of study drug approximately a half hour before initiation of intercourse. Food and alcohol intake were restricted.

Additionally, a subset of patients from 2 of trials were enrolled into a-label extension trial. In the open-label extension trial, all eligible patients were initially assigned to avanafil 100 mg. At any time through the trial, patients could request to have their dose of avanafil increased to 200 mg or decreased to 50 mg based on their individual reply to treatment.

These 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 actually a 4-week recall questionnaire that was administered at baseline

 

and at 4-week intervals during treatment. The IIEF erections domain carries a 30-point total score, where higher scores reflect better erection health. The SEP included diary-based measures of erection health. Patients recorded information regarding each sexual attempt made over the trial. Question 2 of the SEP asks “Were you capable to insert the penis into your second half’s vagina?” Question 3 of the SEP asks “Did your erection go far enough for you to get successful intercourse?”

Email address particulars are shown from the two, Phase 3, randomized, double-blind, placebo-controlled, parallel studies, one inch the ED population (Study 1) plus the other from the diabetic population with ED (Study 2).

Ends up with the General ED Population (Study 1):

was evaluated in 646 men with ED of assorted etiologies (organic, psychogenic, mixed). The mean age was 55.7 years (range 23 to 88 years). The populace was 85.6% White, 13.2% Black,0.9% Asian, and 0.3% of other races. The mean duration of ED was approximately 6.several years. at doses of 50 mg, 100 mg, and 200 mg demonstrated statistically significant improvement to all 3 primary efficacy variables in accordance with placebo (see Table 6).

Table 6: Mean Change From Baseline for Primary Efficacy Variables usually ED Population (Study 1)

Placebo

(N=155)

50 mg

(N=154)

100 mg

(N=157)

200 mg

(N=156)

IIEF EF Domain Score

Endpoint

15.3

18.1

20.9

22.2

Change from baseline†

2.9

5.4

8.3

9.5

p-value*

0.0014

<0.0001

<0.0001

Vaginal Penetration (SEP2)

Endpoint

53.8%

64.3%

73.9%

77.3%

Change from baseline†

7.1%

18.2%

27.2%

29.8%

p-value*

-

0.0009

<0.0001

<0.0001

Successful Intercourse (SEP3)

Endpoint

27.0%

41.3%

57.1%

57.0%

Change from baseline†

14.1%

27.8%

43.4%

44.2%

p-value*

-

0.0002

<0.0001

<0.0001

† Least-square estimate from ANCOVA model

* comparison to placebo for vary from baseline

2 diabetes in a very 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 people 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. With this trial, at doses of 100 mg and 200 mg demonstrated statistically significant improvement in most 3 primary efficacy variables as measured with the erections domain of your IIEF questionnaire; SEP2 and SEP3 (see Table 7).

Table 7: Mean Change From Baseline for Primary Efficacy Variables in ED Population with DM (Study 2)

Placebo

(N=127)

100 mg

(N=126)

200 mg

(N=126)

IIEF EF Domain Score

Endpoint

13.2

15.8

17.3

Change from baseline†

1.8

4.5

5.4

p-value*

-

0.0017

<0.0001

Vaginal Penetration (SEP2)

Endpoint

42.0%

54.0%

63.5%

Change from baseline†

7.5%

21.5%

25.9%

p-value*

-

0.0004

<0.0001

Successful Intercourse (SEP3)

Endpoint

20.5%

34.4%

40.0%

Change from baseline†

13.6%

28.7%

34.0%

p-value*

-

<0.0001

<0.0001

† least-square estimate from ANCOVA model

* comparison to placebo for differ from baseline

 

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