Trial · NCT00853606
Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
NCT00853606, Phase 3, Completed, VIVUS LLC; results first posted 2012-06-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction. Trials, record NCT00853606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00853606
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
- NCT number
- NCT00853606
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 712 participants, actual
- Lead sponsor
- VIVUS LLC
- Conditions
- Erectile Dysfunction
- Interventions
- avanafil
- First posted
- 2009-03-02
- Last updated
- 2012-08-17
- Results first posted
- 2012-06-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Number of participants analyzed represents the Intent-to-Treat population. | percentage of sexual attempts | MEAN |
| PRIMARY | Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina | Baseline, 52 weeks | Number of participants analyzed represents to Intent-to-Treat population. | percentage of sexual attempts | MEAN |
| PRIMARY | Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score | Baseline, End of Treatment | Number of participants analyzed represents the Intent-to-Treat population. For dropouts of missing data, the last observation carried forward convention was used. | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse. | Avanafil | 54.75 | Standard Deviation 35.915 | percentage of sexual attempts | |
| Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina | Avanafil | 36.91 | Standard Deviation 36.142 | percentage of sexual attempts | |
| Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score | Avanafil | 10.3 | Standard Deviation 7.88 | scores on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Avanafil | 712 | |
| Overall Study | COMPLETED | Avanafil | 492 | |
| Overall Study | NOT COMPLETED | Avanafil | 220 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nasopharyngitis | Infections and infestations | Avanafil | 24 | 712 | |
| other | headache | Nervous system disorders | Avanafil | 40 | 712 | |
| other | flushing | Vascular disorders | Avanafil | 25 | 712 | |
| other | nasal congestion | Respiratory, thoracic and mediastinal disorders | Avanafil | 15 | 712 | |
| serious | Acute physchosis | Psychiatric disorders | Avanafil | 1 | 712 | |
| serious | pancreatitis acute | Gastrointestinal disorders | Avanafil | 1 | 712 | |
| serious | femoral artery occlusion | Vascular disorders | Avanafil | 1 | 712 | |
| serious | inguinal hernia | Gastrointestinal disorders | Avanafil | 1 | 712 | |
| serious | syncope vasovagal | Nervous system disorders | Avanafil | 1 | 712 | |
| serious | coronary artery disease | Cardiac disorders | Avanafil | 1 | 712 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avanafil | ||
| Total, other adverse events | Avanafil | 87 | 712 |
| Total, serious adverse events | Avanafil | 11 | 712 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23521325 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00853606
GET https://conductscience.org/api/trials/v1/NCT00853606/registered