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NCT00662441 Clinical Trial

Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00662441
Other study ID # 100578
Secondary ID
Status Completed
Phase Phase 4
First received April 16, 2008
Last updated June 19, 2009
Start date September 2003
Est. completion date June 2004

Study information
Verified date June 2009
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Nigeria: The National Agency for Food and Drug Administration and Control
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Men >/= 18 years of age

- Erectile Dysfunction

Exclusion Criteria:

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
10mg taken 1 hours before sexual intercourse

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Bayer GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary International Index of Erectile Function- Erectile Function domain 8 weeks No
Secondary Global Assessment Questionnaire (GAQ) 8 weeks No
Secondary Safety and tolerability 8 weeks Yes
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05366504 - LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment Phase 2/Phase 3
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02573805 - the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males N/A
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02225548 - Sagene 2014 - Parkinson's Disease and Erectile Dysfunction Phase 4
Completed NCT02587988 - Trial to Evaluate the Efficacy and Safety of HCP1302 Phase 3
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT02945462 - Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED) Phase 1
Completed NCT01698684 - Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction Phase 4
Not yet recruiting NCT01321489 - A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies Phase 3
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Terminated NCT01262833 - Pudendal Assessment in Erectile Dysfunction N/A
Completed NCT01230541 - Effect of Udenafil on Spermatogenesis Phase 1
Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
Completed NCT01037244 - Treatment of Erectile Dysfunction I Phase 3
Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4
Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3

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