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A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.

NCT00668096 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2014-12-25

No results posted yet for this study

Summary

The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

Conditions

Interventions

DRUG

Levitra (Vardenafil, BAY38-9456)

Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity

DRUG

Placebo

Matching Placebo

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2005-01-31
Completion
2005-01-31

Countries

  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00668096 on ClinicalTrials.gov