Erectile Dysfunction
Conditions
Keywords
ED, Erectile Dysfunction, Dysfunction, Erectile
Brief summary
This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.
Interventions
DRUGavanafil
All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.
Sponsors
VIVUS LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successfully completed the entire treatment period in a qualifying study (TA-301 \[NCT00790751\] or TA-302 \[NCT00809471\]); * Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial; * Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial; * Agree to make at least 4 attempts at intercourse each month through the course of this study; * Agree not to use any other treatments for erectile dysfunction during participation in this study. * Provide written informed consent; * Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
* Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314; * Subjects requiring treatment with an excluded medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse. | Baseline, 52 weeks | Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit. |
| Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina | Baseline, 52 weeks | Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit. |
| Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score | Baseline, End of Treatment | Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward. |
Countries
United States
Participant flow
Recruitment details
Subject recruitment occurred at US investigative sites between March 2009 and April 2010.
Participants by arm
| Arm | Count |
|---|---|
| Avanafil All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity. | 712 |
| Total | 712 |
Baseline characteristics
| Characteristic | Avanafil |
|---|---|
| Age Continuous | 56.4 years STANDARD_DEVIATION 10.19 |
| Region of Enrollment United States | 712 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 712 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 87 / 712 |
| serious Total, serious adverse events | 11 / 712 |
Outcome results
Primary
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.
Time frame: Baseline, End of Treatment
Population: Number of participants analyzed represents the Intent-to-Treat population. For dropouts of missing data, the last observation carried forward convention was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avanafil | Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score | 10.3 scores on a scale | Standard Deviation 7.88 |
Primary
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina
Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.
Time frame: Baseline, 52 weeks
Population: Number of participants analyzed represents to Intent-to-Treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avanafil | Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina | 36.91 percentage of sexual attempts | Standard Deviation 36.142 |
Primary
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.
Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.
Time frame: Baseline, 52 weeks
Population: Number of participants analyzed represents the Intent-to-Treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avanafil | Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse. | 54.75 percentage of sexual attempts | Standard Deviation 35.915 |