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

• ClinicalTrials.gov Identifier: NCT00661115
• Recruitment Status: Completed
• First Posted: April 18, 2008
• Last Update Posted: December 16, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: April 15, 2008
• First Posted Date: April 18, 2008
• Last Update Posted Date: December 16, 2014
• Study Start Date: May 2003
• Actual Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 17, 2008): 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. ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 17, 2008)

• Success in penetration and maintenance as recorded in subject diaries [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ]
• Scores for questions 3 and 4 of the IIEF [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ]
• Other IIEF domain scores [ Time Frame: At Week 12 (observed and at LOCF) ]
• Global Assessment Question (GAQ) responses [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ]
• 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) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.
• 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 .
• Brief Summary: To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Erectile Dysfunction

Intervention

• 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
• 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

Study Arms

• Experimental: Arm 1
  Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
• Placebo Comparator: Arm 2
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 15, 2014): 173
• Original Actual Enrollment (submitted: April 17, 2008): 193
• Actual Study Completion Date: February 2004
• Actual Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT00661115
• Other Study ID Numbers: 10695
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bayer
• Original Responsible Party: Bayer HealthCare AG, Therapeutic Area Head
• Current Study Sponsor: Bayer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: December 2014