Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function

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

Official Title
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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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Sildenafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 20 mg daily dosing<br>|
| Active Comparator: Arm 2<br> | Drug: Sildenafil<br>* 100 mg daily dosing<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* Matching placebos<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sperm concentration |  | 24 weeks | 
| Mean sperm count |  | 24 weeks | 
| Sperm morphology |  | 24 weeks | 
| Sperm motility |  | 24 weeks | 
| Reproductive hormones |  | 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 use |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, Sildenafil, Vardenafil, Spermatogenesis, Sperm concentration, Sperm count, Morphology, Motility, Reproductive hormonal