Trial Outcomes & Findings for Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction (NCT NCT01698684)
NCT ID: NCT01698684
Last Updated: 2014-10-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
440 participants
Primary outcome timeframe
Week 0 (Baseline) up to Week 8 (End of Study)
Results posted on
2014-10-27
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: One dose 15 minutes before attempting intercourse
|
Avanafil 100 mg
Avanafil 100 mg: One dose 15 minutes before attempting intercourse
|
Avanafil 200 mg
Avanafil 200 mg: One dose 15 minutes before attempting intercourse
|
|---|---|---|---|
|
Overall Study
STARTED
|
145
|
147
|
148
|
|
Overall Study
ITT Population
|
136
|
139
|
139
|
|
Overall Study
Safety Population
|
143
|
146
|
146
|
|
Overall Study
COMPLETED
|
116
|
124
|
127
|
|
Overall Study
NOT COMPLETED
|
29
|
23
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
Placebo
n=145 Participants
Placebo: One dose 15 minutes before attempting intercourse
|
Avanafil 100 mg
n=147 Participants
Avanafil 100 mg: One dose 15 minutes before attempting intercourse
|
Avanafil 200 mg
n=148 Participants
Avanafil 200 mg: One dose 15 minutes before attempting intercourse
|
Total
n=440 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 10.19 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 10.61 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 10.23 • n=4 Participants
|
|
Age, Customized
<50 Years
|
29 participants
n=5 Participants
|
25 participants
n=7 Participants
|
29 participants
n=5 Participants
|
83 participants
n=4 Participants
|
|
Age, Customized
>=50 to <65 Years
|
74 participants
n=5 Participants
|
78 participants
n=7 Participants
|
76 participants
n=5 Participants
|
228 participants
n=4 Participants
|
|
Age, Customized
>=65 Years
|
42 participants
n=5 Participants
|
44 participants
n=7 Participants
|
43 participants
n=5 Participants
|
129 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
440 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
102 participants
n=5 Participants
|
107 participants
n=7 Participants
|
124 participants
n=5 Participants
|
333 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
37 participants
n=5 Participants
|
35 participants
n=7 Participants
|
22 participants
n=5 Participants
|
94 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
145 participants
n=5 Participants
|
147 participants
n=7 Participants
|
148 participants
n=5 Participants
|
440 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 0 (Baseline) up to Week 8 (End of Study)Population: The intent-to-treat (ITT) population consists of all subjects who are randomized, take at least 1 dose of study medication, and have at least 1 post-dose efficacy assessment.
Outcome measures
| Measure |
Placebo
n=136 Participants
Placebo: One dose 15 minutes before attempting intercourse
|
Avanafil 100 mg
n=139 Participants
Avanafil 100 mg: One dose 15 minutes before attempting intercourse
|
Avanafil 200 mg
n=139 Participants
Avanafil 200 mg: One dose 15 minutes before attempting intercourse
|
|---|---|---|---|
|
Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing
|
14.9 percentage of successes
Standard Deviation 25.1
|
25.9 percentage of successes
Standard Deviation 32.0
|
29.1 percentage of successes
Standard Deviation 34
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Avanafil 100 mg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Avanafil 200 mg
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=143 participants at risk
Placebo: One dose 15 minutes before attempting intercourse
|
Avanafil 100 mg
n=146 participants at risk
Avanafil 100 mg: One dose 15 minutes before attempting intercourse
|
Avanafil 200 mg
n=146 participants at risk
Avanafil 200 mg: One dose 15 minutes before attempting intercourse
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.70%
1/143 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.00%
0/146 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.00%
0/146 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.70%
1/143 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.00%
0/146 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.00%
0/146 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/143 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.68%
1/146 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.68%
1/146 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/143 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.68%
1/146 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.00%
0/146 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/143 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.68%
1/146 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.00%
0/146 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/143 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.68%
1/146 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.00%
0/146 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/143 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.00%
0/146 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.68%
1/146 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/143 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.00%
0/146 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.68%
1/146 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
Other adverse events
| Measure |
Placebo
n=143 participants at risk
Placebo: One dose 15 minutes before attempting intercourse
|
Avanafil 100 mg
n=146 participants at risk
Avanafil 100 mg: One dose 15 minutes before attempting intercourse
|
Avanafil 200 mg
n=146 participants at risk
Avanafil 200 mg: One dose 15 minutes before attempting intercourse
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.70%
1/143 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
1.4%
2/146 • Number of events 2 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
8.9%
13/146 • Number of events 37 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/143 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.68%
1/146 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
4.1%
6/146 • Number of events 9 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
9/143 • Number of events 9 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
2.1%
3/146 • Number of events 3 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
1.4%
2/146 • Number of events 2 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/143 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.00%
0/146 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
2.1%
3/146 • Number of events 3 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
3/143 • Number of events 3 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
0.68%
1/146 • Number of events 1 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
1.4%
2/146 • Number of events 2 • Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)
The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.
|
Additional Information
Wesley W Day, PhD
Vivus, Inc.
Phone: 650-934-5200
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60