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

December 26, 2014 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
      • Tempe, Arizona, United States, 85282
    • 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
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
    • Florida
      • Aventura, Florida, United States, 33180
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0330
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
      • Rochester, Minnesota, United States, 55905
    • New York
      • Great Neck, New York, United States, 11021
      • New York, New York, United States, 10016-4576
    • Ohio
      • Cincinnati, Ohio, United States, 45212-2787
    • Texas
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean sperm concentration
Time Frame: 24 weeks
24 weeks
Mean sperm count
Time Frame: 24 weeks
24 weeks
Sperm morphology
Time Frame: 24 weeks
24 weeks
Sperm motility
Time Frame: 24 weeks
24 weeks
Reproductive hormones
Time Frame: 24 weeks
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
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 26, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11520

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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