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Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)

NCT00809471 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2012-08-17

Study results available
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Summary

This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to placebo in diabetic men with mild to severe erectile dysfunction.

Conditions

Interventions

DRUG

placebo

30 minutes orally prior to initiation of sexual activity

DRUG

avanafil

30 minutes orally prior to initiation of sexual activity

DRUG

avanafil

30 minutes orally prior to initiation of sexual activity

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Irwin Goldstein, MD · San Diego Sexual Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-02-28
Completion
2010-02-28

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 NCT00809471 on ClinicalTrials.gov