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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00655590
First received: April 4, 2008
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

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 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean sperm concentration [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Mean sperm count [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Sperm morphology [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Sperm motility [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Reproductive hormones [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 191
Study Start Date: January 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655590

Locations
United States, Arizona
Phoenix, Arizona, United States, 85023
Tempe, Arizona, United States, 85282
United States, California
Beverly Hills, California, United States, 90212
La Mesa, California, United States, 91942-3058
Laguna Hills, California, United States, 92653
San Diego, California, United States, 92128
Torrance, California, United States, 90502-2004
Van Nuys, California, United States, 91405
United States, Connecticut
Waterbury, Connecticut, United States, 06708
United States, Florida
Aventura, Florida, United States, 33180
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0330
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
Rochester, Minnesota, United States, 55905
United States, New York
Great Neck, New York, United States, 11021
New York, New York, United States, 10016-4576
United States, Ohio
Cincinnati, Ohio, United States, 45212-2787
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00655590     History of Changes
Other Study ID Numbers: 11520
Study First Received: April 4, 2008
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Erectile Dysfunction
Sildenafil
Vardenafil
Spermatogenesis
Sperm concentration
Sperm count
Morphology
Motility
Reproductive hormonal

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014