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Completed

NCT Number: NCT00661115

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

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

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Bangalore, Karnataka, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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 .

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Apr 18, 2008
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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