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

NCT00895011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2012-10-01

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

One dose 30 minutes prior to initiation of sexual activity

DRUG

Avanafil

One dose 30 minutes prior to initiation of sexual activity

DRUG

Avanafil

One dose 30 minutes prior to initiation of sexual activity

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • John Mulhall, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00895011 on ClinicalTrials.gov