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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00655590

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

11.1

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Sildenafil Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Levitra (Vardenafil, BAY38-9456)

20 mg daily dosing

Active Comparator: Arm 2

Drug: Sildenafil

100 mg daily dosing

Placebo Comparator: Arm 3

Drug: Placebo

Matching placebos

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
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
5	Laguna Hills	California	United States	92653
6	San Diego	California	United States	92128
7	Torrance	California	United States	90502-2004
8	Van Nuys	California	United States	91405
9	Waterbury	Connecticut	United States	06708
10	Aventura	Florida	United States	33180
11	New Orleans	Louisiana	United States	70112
12	Ann Arbor	Michigan	United States	48109-0330
13	Minneapolis	Minnesota	United States	55455
14	Rochester	Minnesota	United States	55905
15	Great Neck	New York	United States	11021
16	New York	New York	United States	10016-4576
17	Cincinnati	Ohio	United States	45212-2787
18	San Antonio	Texas	United States	78229