NCT00662441

Brief Summary

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

First QC Date

April 16, 2008

Last Update Submit

June 19, 2009

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionVardenafil

Outcome Measures

Primary Outcomes (1)

  • International Index of Erectile Function- Erectile Function domain

    8 weeks

Secondary Outcomes (2)

  • Global Assessment Questionnaire (GAQ)

    8 weeks

  • Safety and tolerability

    8 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

10mg taken 1 hours before sexual intercourse

Arm 1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men \>/= 18 years of age
  • Erectile Dysfunction

You may not qualify if:

  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

September 1, 2003

Study Completion

June 1, 2004

Last Updated

June 22, 2009

Record last verified: 2009-06