Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Sildenafil (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on
sperm function
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Primary outcome: 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
Secondary outcome: Mean sperm concentrationMean sperm count Sperm morphology Sperm motility Reproductive hormones 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
Eligibility
Minimum age: 25 Years.
Maximum age: 64 Years.
Gender(s): Male.
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
Locations and Contacts
Phoenix, Arizona 85023, United States
Tempe, Arizona 85282, United States
Van Nuys, California 91405, United States
La Mesa, California 91942-3058, United States
Beverly Hills, California 90212, United States
Torrance, California 90502-2004, United States
San Diego, California 92128, United States
New Orleans, Louisiana 70112, United States
Ann Arbor, Michigan 48109-0330, United States
Minneapolis, Minnesota 55455, United States
New York, New York 10016-4576, United States
Great Neck, New York 11021, United States
Cincinnati, Ohio 45212-2787, United States
San Antonio, Texas 78229, United States
Additional Information
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Starting date: January 2005
Ending date: June 2006
Last updated: April 4, 2008
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