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To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00661115
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo Controlled, Multi-center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men With Erectile Dysfunction .
Study Start Date : May 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks
Placebo Comparator: Arm 2 Drug: Placebo
Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15 [ Time Frame: At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts. ]

Secondary Outcome Measures :
  1. Success in penetration and maintenance as recorded in subject diaries [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ]
  2. Scores for questions 3 and 4 of the IIEF [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ]
  3. Other IIEF domain scores [ Time Frame: At Week 12 (observed and at LOCF) ]
  4. Global Assessment Question (GAQ) responses [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ]
  5. Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use. [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
  • having at least a 50% failure rate of sexual intercourse attempts during the run-in phase

Exclusion Criteria:

  • Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.
  • Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.
  • Subjects could not be on androgens/anti-androgens or alpha blockers.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661115


Locations
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India
Bangalore, Karnataka, India, 560010
Bangalore, Karnataka, India, 560054
Belagum, Karnataka, India, 590010
Mumbai, Maharashtra, India, 400007
Mumbai, Maharashtra, India, 400022
Madurai, Tamilnadu, India, 625107
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00661115    
Other Study ID Numbers: 10695
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Erectile dysfunction
Sexual Dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Sexual Dysfunction, Physiological
Male Urogenital Diseases
Sexual Dysfunctions, Psychological
Mental Disorders
 Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents