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NCT00895011 · ClinicalTrials.gov registry record · Phase 3

Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy

A Phase 3 study, sponsored by VIVUS.

Completed
Registry status
Phase 3
Development phase
298
Enrollment target

NCT00895011: Completed Phase 3 study, sponsored by VIVUS.

NCT00895011 is a Phase 3 study that has completed, run by VIVUS. The registered enrollment target is 298 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00895011, a Phase 3 study, has completed, sponsored by VIVUS.

COMPLETED
Registry status
Phase 3
Development phase
298 participants
Enrollment target

Study Summary

The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing radical prostatectomy.

Primary Outcome

Data presented as mean change from baseline 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?"

Interventions

  • DRUG Placebo
  • DRUG Avanafil

Trial Details

FieldValue
Enrollment Target 298 participants
Start Date 2009-04
Est. Completion 2011-04
Phase Phase 3
VIVUS

35 total trials

What the finished NCT00895011 record still lists

NCT00895011 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00895011 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00895011 about?

NCT00895011 is a clinical study titled "Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy". The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing radical prostatectomy.

What is the current status of trial NCT00895011?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 298 participants. The study started on 2009-04. Estimated completion is 2011-04.

What interventions are being tested in trial NCT00895011?

The interventions under investigation include: Placebo (DRUG), Avanafil (DRUG).

Who is sponsoring clinical trial NCT00895011?

This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00895011's enrollment target sits among peer trials

298 1162nd of 2000 higher than 838 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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Source: ClinicalTrials.gov NCT00895011, the US trial registry maintained by the National Library of Medicine. NCT00895011 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.