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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| avanafil | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| avanafil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 52 weeks |
| 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. | Baseline, 52 weeks |
| 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. | Baseline, End of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew McCullough, MD | NYU Urology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23521325 | Derived | Belkoff LH, McCullough A, Goldstein I, Jones L, Bowden CH, DiDonato K, Trask B, Day WW. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Int J Clin Pract. 2013 Apr;67(4):333-41. doi: 10.1111/ijcp.12065. |
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Subject recruitment occurred at US investigative sites between March 2009 and April 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Homewood |
| Alabama |
| 35209 |
| United States |
| Research Site | Tucson | Arizona | 85712 | United States |
| Research Site | Sacramento | California | 95821 | United States |
| Research Site | San Diego | California | 92120 | United States |
| Research Site | San Diego | California | 92123 | United States |
| Research Site | Waterbury | Connecticut | 06708 | United States |
| Research Site | Clearwater | Florida | 33756 | United States |
| Research Site | Clearwater | Florida | 33761 | United States |
| Research Site | Coral Gables | Florida | 33134 | United States |
| Research Site | Hialeah | Florida | 33012 | United States |
| Research Site | Jacksonville | Florida | 32205 | United States |
| Research Site | Jupiter | Florida | 33458 | United States |
| Research Site | Ocala | Florida | 34471 | United States |
| Research Site | Pembroke Pines | Florida | 33024 | United States |
| Research Site | Ponte Vedra | Florida | 32081 | United States |
| Research Site | Tampa | Florida | 33624 | United States |
| Research Site | Sandy Springs | Georgia | 30328 | United States |
| Research Site | Wichita | Kansas | 67205 | United States |
| Research Site | Madisonville | Kentucky | 42431 | United States |
| Research Site | Shreveport | Louisiana | 71106 | United States |
| Research Site | Kansas City | Missouri | 64114 | United States |
| Research Site | Lawrenceville | New Jersey | 08648 | United States |
| Research Site | Albany | New York | 12206 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Cary | North Carolina | 27518 | United States |
| Research Site | Charlotte | North Carolina | 28207 | United States |
| Research Site | Charlotte | North Carolina | 28209 | United States |
| Research Site | Harrisburg | North Carolina | 28075 | United States |
| Research Site | Hickory | North Carolina | 28601 | United States |
| Research Site | Raleigh | North Carolina | 27609 | United States |
| Research Site | Salisbury | North Carolina | 28144 | United States |
| Research Site | Wilmington | North Carolina | 28401 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Cleveland | Ohio | 44122 | United States |
| Research Site | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Research Site | Lancaster | Pennsylvania | 17601 | United States |
| Research Site | El Paso | Texas | 79935 | United States |
| Research Site | Houston | Texas | 77074 | United States |
| Research Site | Spring | Texas | 77386 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants analyzed represents the Intent-to-Treat population. | Posted | Mean | Standard Deviation | percentage of sexual attempts | Baseline, 52 weeks |
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| 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. | Number of participants analyzed represents to Intent-to-Treat population. | Posted | Mean | Standard Deviation | percentage of sexual attempts | Baseline, 52 weeks |
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| 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. | Number of participants analyzed represents the Intent-to-Treat population. For dropouts of missing data, the last observation carried forward convention was used. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, End of Treatment |
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AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who received at least one dose of avanafil during TA-314 and who have any safety data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 11 | 712 | 87 | 712 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute physchosis | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| pancreatitis acute | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| femoral artery occlusion | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
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| inguinal hernia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
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| syncope vasovagal | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| coronary artery disease | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
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| cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
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| subdural hematoma | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
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| atrial fibrillation | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
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| aortic valve stenosis | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
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| small intestinal obstruction | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
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| cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
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| cardiac failure congestive | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| flushing | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
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| nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
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After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution & PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wesley W Day PhD | Vivus, Inc | 650-934-5200 |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C553414 | avanafil |
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