A Study to Assess the Efficacy and Safety of Vardenafil in the Treatment of Male Patients With Erectile Dysfunction

NCT00654914 | Completed Phase 3

• 1 other identifier: 10781
• Study Type: interventional
• Target: 527
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to assess the efficacy together with safety of a flexible regimen, for a period of twelve weeks, of three doses (5 mg, 10mg and 20mg) of Bay 38-9456, a phosphodiesterase type V inhibitor, in males with erectile dysfunction treated with sildenafil in the previous \<6 months .At entry, once the Inclusion and Exclusion criteria are confirmed, the study medication will be administered for twelve weeks in an open label design. Vardenafil will be administered, as needed, at a fix dose of 10 mg once daily for the first four weeks of treatment. At the Investigators' discretion, on the basis of efficacy and safety evaluations, the patients may, then, receive the same dose strength of their assigned study medication or, at the subsequent clinic visit(s), the next lower dose (5 mg vardenafil) or the next higher dose (20 mg vardenafil) for the subsequent four weeks of treatment. Previous dose level of vardenafil is either maintained, increased or decreased by one step according to the three applicable dose strengths (5 mg, 10 mg, 20 mg ). The highest dosage of vardenafil (20 mg) per day will not be exceeded. After twelve weeks of treatment, the patient will be contacted twenty four hours following the last visit in order to collect data concerning serious adverse events.

Conditions

Erectile Dysfunction

Keywords

Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• Percentage of success rate at the end of treatment period versus baseline.

  At baseline, after 12 weeks

Secondary Outcomes (3)

• The Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF-Appendix 10.3) calculated as the sum of scores from Questions 1-5 and 15 at Visit 5 using the last Visit vs baseline.

  Baseline, after 4 weeks, after 12 weeks

• Global Assessment Question

  Baseline, after 4 weeks, after 12 weeks

• Italian validated Version of SF-12 Health Survey

  Baseline, after 12 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Levitra (Vardenafil, BAY38-9456) DRUG

10 mg per dose of vardenafil for the first four weeks. A further 8 weeks ( in two treatment periods of four weeks, respectively) where patients will either maintain the previous dosage regimen or will step up to 20 mg per dose of vardenafil or will step down to 5 mg per dose of vardenafil, at interval visits of four weeks .

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males with erectile dysfunction for more than 6 months and no more than three years according to the NIH Consensus definition (the inability to achieve and maintain penile erection sufficient for satisfactory sexual intercourse)
• Stable, heterosexual relationship for more than 6 months
• Age range: 18 years and older
• Documented, written Informed Consent.

You may not qualify if:

• A) Previous or current Medical Conditions
• Any unstable medical or psychiatric condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
• Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie disease) that would significantly impair erectile function.
• Primary hypoactive sexual desire
• Erectile dysfunction after spinal cord injury
• Retinitis pigmentosa.
• History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.
• Unstable angina pectoris
• History of myocardial infarction, stroke, electrocardiographic ischaemia (except stable angina), or life-threatening arrhythmia, within the prior 6 months.
• Atrial tachyarrhythmia (e.g. atrial fibrillation/flutter) with a heart rate of \> 100 beats per minute at screening
• Severe chronic liver disease or liver function abnormalities
• Clinically significant chronic haematological disease or bleeding disorder
• History of significant peptic ulcer disease within one year of Visit 1.
• Resting hypotension (a resting systolic blood pressure of \<90 mm Hg) or hypertension (a resting systolic blood pressure \>170 mm Hg or a resting diastolic blood pressure \>110 mm Hg)
• Symptomatic postural hypotension within the six months of Visit 1.

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 9, 2008
• Study Start: May 1, 2003
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: December 23, 2014

Record last verified: 2014-12