Clinical trial NCT00655590: Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Sildenafil
Vardenafil
Spermatogenesis
Sperm concentration
Sperm count
Morphology
Motility
Reproductive hormonal
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 200
Sex: MALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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 use
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean sperm concentration
timeFrame: 24 weeks
measure: Mean sperm count
timeFrame: 24 weeks
measure: Sperm morphology
timeFrame: 24 weeks
measure: Sperm motility
timeFrame: 24 weeks
measure: Reproductive hormones
timeFrame: 24 weeks
measure: 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 use
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Van Nuys
country: United States
state: California
city: Waterbury
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: New Orleans
country: United States
state: Louisiana
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Great Neck
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: