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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00661115
First received: April 15, 2008
Last updated: October 9, 2013
Last verified: October 2013
  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:


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
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00661115     History of Changes
Other Study ID Numbers: 10695
Study First Received: April 15, 2008
Last Updated: October 9, 2013
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
Urological Agents

ClinicalTrials.gov processed this record on August 28, 2014