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NCT00853606 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
A Phase 3 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 3
- Development phase
- 712
- Enrollment target
NCT00853606: Completed Phase 3 study, sponsored by VIVUS.
NCT00853606 is a Phase 3 study that has completed, run by VIVUS. The registered enrollment target is 712 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853606, a Phase 3 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 712 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG avanafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 712 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
What the finished NCT00853606 record still lists
NCT00853606 is an interventional study that assigns participants to a tested intervention. The registered 712 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which avanafil is the first listed.
NCT00853606 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853606 about?
NCT00853606 is a clinical study titled "Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction". 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.
What is the current status of trial NCT00853606?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 712 participants. The study started on 2009-03. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00853606?
The interventions under investigation include: avanafil (DRUG).
Who is sponsoring clinical trial NCT00853606?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00853606's enrollment target sits among peer trials
712 499th of 2000 higher than 1,500 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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