NCT00655590

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

1.4 years

First QC Date

April 4, 2008

Last Update Submit

December 26, 2014

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionSildenafilVardenafilSpermatogenesisSperm concentrationSperm countMorphologyMotilityReproductive hormonal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Mean sperm concentration

    24 weeks

  • Mean sperm count

    24 weeks

  • Sperm morphology

    24 weeks

  • Sperm motility

    24 weeks

  • Reproductive hormones

    24 weeks

  • +1 more secondary outcomes

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

ACTIVE COMPARATOR
Drug: Sildenafil

Arm 3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

20 mg daily dosing

Arm 1
SildenafilDRUG

100 mg daily dosing

Arm 2
PlaceboDRUG

Matching placebos

Arm 3

Eligibility Criteria

Age25 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Phoenix, Arizona, 85023, United States

Location

Unknown Facility

Tempe, Arizona, 85282, United States

Location

Unknown Facility

Beverly Hills, California, 90212, United States

Location

Unknown Facility

La Mesa, California, 91942-3058, United States

Location

Unknown Facility

Laguna Hills, California, 92653, United States

Location

Unknown Facility

San Diego, California, 92128, United States

Location

Unknown Facility

Torrance, California, 90502-2004, United States

Location

Unknown Facility

Van Nuys, California, 91405, United States

Location

Unknown Facility

Waterbury, Connecticut, 06708, United States

Location

Unknown Facility

Aventura, Florida, 33180, United States

Location

Unknown Facility

New Orleans, Louisiana, 70112, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48109-0330, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55455, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Great Neck, New York, 11021, United States

Location

Unknown Facility

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

Location

Unknown Facility

Cincinnati, Ohio, 45212-2787, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Vardenafil DihydrochlorideSildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 10, 2008

Study Start

January 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

US(18)