Trial Condition(s):

Erectile Dysfunction

Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function

Bayer Identifier:

11520

ClinicalTrials.gov Identifier:

NCT00655590

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function

Inclusion Criteria
- Healthy male subjects or men with ED aged 25 - 64
 - Baseline sperm conc. of > 20 mio / ml- Normal World Health Organization A+B+C sperm mortality > 50%- Normal sperm morphology (WHO, 1992 manual criteria) > 30% and - 1.0 mL ejaculate volume at each of the 3 analyses during the screening phase.
Exclusion Criteria
- Presence of any psychological or physiological abnormalities that in the opinion of the Investigator would significantly impair sexual performance or ability to provide semen samples according to the protocol- Spinal cord injury
 - History of surgical prostatectomy
 - Other exclusion criteria apply according to US Product Information

Trial Summary

Enrollment Goal
200
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

West Coast Clinical Research

Van Nuys, United States, 91405

Status
Completed
 
Locations

Urology Specialists, PC

Waterbury, United States, 06708

Status
Terminated
 
Locations

Center for Urological Research

La Mesa, United States, 91942-3058

Status
Completed
 
Locations

South Florida Medical Research

Aventura, United States, 33180

Status
Terminated
 
Locations

Tulane Medical Center

New Orleans, United States, 70112

Status
Completed
 
Locations

Harbor - UCLA Medical Center

Torrance, United States, 90502-2004

Status
Completed
 
Locations

South Coast Urological Medical Group

Laguna Hills, United States, 92653

Status
Terminated
 
Locations

Arizona Research Center, Inc.

Phoenix, United States, 85023

Status
Completed
 
Locations

Urology San Antonio Research, PA

San Antonio, United States, 78229

Status
Completed
 
Locations

NYU Langone Medical Center

New York, United States, 10016-4576

Status
Completed
 
Locations

University of Michigan Health System

Ann Arbor, United States, 48109-0330

Status
Completed
 
Locations

Office of Dr. Bruce Gilbert, MD

Great Neck, United States, 11021

Status
Completed
 
Locations

The Male Clinic

Beverly Hills, United States, 90212

Status
Completed
 
Locations

The Urology Group

Cincinnati, United States, 45212-2787

Status
Completed
 
Locations

Scripps Clinic

San Diego, United States, 92128

Status
Completed
 
Locations

Tempe Primary Care Associates, PC

Tempe, United States, 85282

Status
Completed
 
Locations

University of Minnesota

Minneapolis, United States, 55455

Status
Completed
 
Locations

Mayo Clinic - Rochester

Rochester, United States, 55905

Status
Terminated
 

Trial Design