check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

100578

ClinicalTrials.gov Identifier:

NCT00662441

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluating of the efficacy and safety of Vardenafil in subjects with erectile dysfunction

Trial purpose

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).

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Men >/= 18 years of age
    - Erectile Dysfunction
  • - History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
    - Nitrate therapy
    - Other exclusion criteria apply according to the Summary of Product Characteristics

Trial summary

Enrollment Goal
102
Trial Dates
August 2003 - June 2004
Phase
Phase 4
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Nigeria

Primary Outcome

  • International Index of Erectile Function- Erectile Function domain
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Global Assessment Questionnaire (GAQ)
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Open-label, multi-centre, study of Levitra 10 mg once a day in males with erectile dysfunction was carried out in four centres namely Lagos, Port Harcourt, Enuge and Maiduguri at their University Teaching Hospitals
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
1

Additional Information

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