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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00661115
First received: April 15, 2008
Last updated: June 19, 2009
Last verified: June 2009
History of Changes
  Purpose

To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 .

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success in penetration and maintenance as recorded in subject diaries [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ] [ Designated as safety issue: No ]
  • Scores for questions 3 and 4 of the IIEF [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ] [ Designated as safety issue: No ]
  • Other IIEF domain scores [ Time Frame: At Week 12 (observed and at LOCF) ] [ Designated as safety issue: No ]
  • Global Assessment Question (GAQ) responses [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 193
Study Start Date: May 2003
Study Completion Date: February 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661115

Locations
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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00661115     History of Changes
Other Study ID Numbers: 10695
Study First Received: April 15, 2008
Last Updated: June 19, 2009
Health Authority: India: Drugs Controller General of India

Keywords provided by Bayer:
Erectile dysfunction
Sexual Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013