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Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levitra (Vardenafil, BAY38-9456) | Drug | 20 mg daily dosing |
| |
| Sildenafil |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean sperm concentration | 24 weeks | |
| Mean sperm count | 24 weeks | |
| Sperm morphology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85023 | United States | |||
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| Drug |
100 mg daily dosing |
|
| Placebo | Drug | Matching placebos |
|
| 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 |
| Tempe |
| Arizona |
| 85282 |
| United States |
| Beverly Hills | California | 90212 | United States |
| La Mesa | California | 91942-3058 | United States |
| Laguna Hills | California | 92653 | United States |
| San Diego | California | 92128 | United States |
| Torrance | California | 90502-2004 | United States |
| Van Nuys | California | 91405 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Aventura | Florida | 33180 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Ann Arbor | Michigan | 48109-0330 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Rochester | Minnesota | 55905 | United States |
| Great Neck | New York | 11021 | United States |
| New York | New York | 10016-4576 | United States |
| Cincinnati | Ohio | 45212-2787 | United States |
| San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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