Status:
COMPLETED
Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function
Lead Sponsor:
Bayer
Conditions:
Erectile Dysfunction
Eligibility:
MALE
25-64 years
Phase:
PHASE4
Brief Summary
Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00655590
Start Date
January 1 2005
End Date
June 1 2006
Last Update
December 30 2014
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix, Arizona, United States, 85023
2
Tempe, Arizona, United States, 85282
3
Beverly Hills, California, United States, 90212
4
La Mesa, California, United States, 91942-3058