Erectile Dysfunction
Conditions
Keywords
ED
Brief summary
The objectives of this study are to examine the therapeutic effects of two doses of avanafil after dosing in men with erectile dysfunction
Interventions
DRUGPlacebo
One dose 15 minutes before attempting intercourse
DRUGAvanafil 100 mg
One dose 15 minutes before attempting intercourse
DRUGAvanafil 200 mg
One dose 15 minutes before attempting intercourse
Sponsors
VIVUS LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males ≥ 18 years of age; * Minimum 6 months of erectile dysfunction; * In a monogamous, heterosexual relationship for at least 3 months; * Agree to make at least 4 attempts at intercourse per month; * Provide written informed consent; * Agree not to use any other ED treatments for erectile dysfunction; * Willing and able to comply with all study requirements.
Exclusion criteria
* Allergy or hypersensitivity to PDE5 inhibitors; * History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor; * Concomitant use of one or more of the following medications: * Other prescription or OTC drugs known to interfere with metabolism by the CYP 3A4 enzyme; * Dose of an alpha blocker that has not been stable for at least 14 days; * Any nitrate; * ED as a consequence of advanced neurologic disease, spinal cord injury,or radical prostatectomy; * Myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months; * Unstable angina, angina with sexual intercourse, or congestive heart failure \> NYHA Class II; * Poorly controlled type 1 or type 2 diabetes; * Evidence of prostate cancer or previous radical prostatectomy; * Untreated hypogonadism or total testosterone levels outside normal reference range; * Abnormal laboratory value(s) judged to be clinically significant by the investigator; * Positive urine drug screen; * History of retinitis pigmentosa, nonarteritic anterior ischemic optic neuropathy or glaucoma; * Previous participation in any other study with avanafil; * Use of any other investigational medication or device for any indication within 30 days prior to enrollment or at any time during this study; * Evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity or confound the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing | Week 0 (Baseline) up to Week 8 (End of Study) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: One dose 15 minutes before attempting intercourse | 145 |
| Avanafil 100 mg Avanafil 100 mg: One dose 15 minutes before attempting intercourse | 147 |
| Avanafil 200 mg Avanafil 200 mg: One dose 15 minutes before attempting intercourse | 148 |
| Total | 440 |
Baseline characteristics
| Characteristic | Placebo | Avanafil 100 mg | Avanafil 200 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 9.92 | 58.5 years STANDARD_DEVIATION 10.19 | 57.9 years STANDARD_DEVIATION 10.61 | 58.2 years STANDARD_DEVIATION 10.23 |
| Age, Customized >=50 to <65 Years | 74 participants | 78 participants | 76 participants | 228 participants |
| Age, Customized <50 Years | 29 participants | 25 participants | 29 participants | 83 participants |
| Age, Customized >=65 Years | 42 participants | 44 participants | 43 participants | 129 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 participants | 1 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 3 participants | 1 participants | 7 participants |
| Race/Ethnicity, Customized Black or African American | 37 participants | 35 participants | 22 participants | 94 participants |
| Race/Ethnicity, Customized Multiple Races | 1 participants | 1 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized White | 102 participants | 107 participants | 124 participants | 333 participants |
| Region of Enrollment United States | 145 participants | 147 participants | 148 participants | 440 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 145 Participants | 147 Participants | 148 Participants | 440 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 143 | 7 / 146 | 26 / 146 |
| serious Total, serious adverse events | 2 / 143 | 4 / 146 | 3 / 146 |
Outcome results
Primary
Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Avanafil 100 mg | Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing | 25.9 percentage of successes | Standard Deviation 32 |
| Avanafil 200 mg | Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing | 29.1 percentage of successes | Standard Deviation 34 |