Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function
NCT ID: NCT00655590
Last Updated: 2014-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2005-01-31
2006-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Levitra (Vardenafil, BAY38-9456)
20 mg daily dosing
Arm 2
Sildenafil
100 mg daily dosing
Arm 3
Placebo
Matching placebos
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Levitra (Vardenafil, BAY38-9456)
20 mg daily dosing
Sildenafil
100 mg daily dosing
Placebo
Matching placebos
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* History of surgical prostatectomy
25 Years
64 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Tempe, Arizona, United States
Beverly Hills, California, United States
La Mesa, California, United States
Laguna Hills, California, United States
San Diego, California, United States
Torrance, California, United States
Van Nuys, California, United States
Waterbury, Connecticut, United States
Aventura, Florida, United States
New Orleans, Louisiana, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Great Neck, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11520
Identifier Type: -
Identifier Source: org_study_id