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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00655590

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil Sildenafil citrate Vardenafil

U.S. FDA Resources

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

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 20 mg daily dosing
Arm 2: Active Comparator	Drug: Sildenafil 100 mg daily dosing
Arm 3: Placebo Comparator	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

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

Van Nuys, California, United States, 91405

La Mesa, California, United States, 91942-3058

Beverly Hills, California, United States, 90212

Torrance, California, United States, 90502-2004

Laguna Hills, California, United States, 92653

San Diego, California, United States, 92128
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

New York, New York, United States, 10016-4576

Great Neck, New York, United States, 11021
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:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer HealthCare Pharmaceuticals Inc. ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	11520
Study First Received:	April 4, 2008
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00655590 History of Changes
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:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Sildenafil
Cardiovascular Agents
Genital Diseases, Male
Sexual and Gender Disorders

Pharmacologic Actions
Sexual Dysfunction, Physiological
Vardenafil
Phosphodiesterase Inhibitors
Mental Disorders
Therapeutic Uses
Erectile Dysfunction

ClinicalTrials.gov processed this record on February 08, 2010