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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations West Coast Clinical Research Van Nuys, United States, 91405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urology Specialists, PC Waterbury, United States, 06708 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Urological Research La Mesa, United States, 91942-3058 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Florida Medical Research Aventura, United States, 33180 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tulane Medical Center New Orleans, United States, 70112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Harbor - UCLA Medical Center Torrance, United States, 90502-2004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Coast Urological Medical Group Laguna Hills, United States, 92653 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arizona Research Center, Inc. Phoenix, United States, 85023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urology San Antonio Research, PA San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NYU Langone Medical Center New York, United States, 10016-4576 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Michigan Health System Ann Arbor, United States, 48109-0330 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Bruce Gilbert, MD Great Neck, United States, 11021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Male Clinic Beverly Hills, United States, 90212 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Urology Group Cincinnati, United States, 45212-2787 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scripps Clinic San Diego, United States, 92128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tempe Primary Care Associates, PC Tempe, United States, 85282 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Minnesota Minneapolis, United States, 55455 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mayo Clinic - Rochester Rochester, United States, 55905 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double-blind, placebo controlled, parallel arm, multicenter trial assessing the effect of daily treatment of vardenafil 20 mg or sildenafil 100 mg compared to placebo on spermatogenesis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Proportion of vardenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo after repeated useTimeframe: 24 weeks
Secondary Outcome
- Mean sperm concentrationTimeframe: 24 weeks
- Mean sperm countTimeframe: 24 weeks
- Sperm morphologyTimeframe: 24 weeks
- Sperm motilityTimeframe: 24 weeks
- Reproductive hormonesTimeframe: 24 weeks
- Proportion of sildenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo and vardenafil after repeated useTimeframe: 24 weeks
Additional Information
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