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Clinical Proof-of-concept Study for the Combination BAY60-4552 / Vardenafil for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 Inhibitors

NCT01168817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2014-11-04

No results posted yet for this study

Summary

This study examines the efficacy and safety of the combination treatment BAY60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with PDE5 (Phosphodiesterase 5) inhibitors.

Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of PDE5 inhibitor therapy given alone.

Patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3 chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone, or placebo. Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last four weeks Patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.

Conditions

Interventions

DRUG

BAY60-4552 plus Vardenafil

Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)

DRUG

Vardenafil

Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)

DRUG

Placebo

Treatment with 3 tablets once daily for 4 weeks (Placebo)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Finland
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden

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 NCT01168817 on ClinicalTrials.gov