Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in
males with erectile dysfunction, and their female partners' sexual quality of life.
Clinical Details
Official title: A Randomized, Double Blind, Parallel Group, Multi-Center Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction, and Their Female Partners' Sexual Quality of Life.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary measures of efficacy in this study will be improved success of erection maintenance in men with ED and improvement in female partner's sexual quality of life.
Secondary outcome: SEP3 at weeks 4 and 12 of treatment compared to placebo.Additional Patient Diary questions at 4 weeks, 8 weeks, 12 weeks, LOCF, and over entire treatment period compared to placebo. Per-subject success rates will be calculated as the number of successes divided by the number of sexual attempts with a resp Global assessment question (GAQ) at weeks 4 and 12 of treatment compared to placebo Global confidence question (GCQ) at 12 weeks of treatment compared to placebo. The score for the IIEF questionnaire EF domain (IIEF-EF) at weeks 4, 12, and LOCF of treatment compared to placebo Scores from the Treatment Satisfaction Scale (TSS) -- Subject Active Medication module at week 12 and LOCF of treatment compared to placebo. The TSS is a self-report measure of subject and partner's satisfaction with various aspects of erectile function Scores from the mSLQQ-QOL at week 12 and LOCF of treatment compared to placebo Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) at week 12 of treatment compared to placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Males who have had ED for at least six months according to the National Institutes of
Health (NIH) Consensus Conference December 7-9, 1992 (inability to attain and/or
maintain penile erection sufficient for satisfactory sexual performance).
- Stable, heterosexual relationship for more than 6 months.
- Males 18 years, and older.
- Written informed consent obtained.
- The subject and his female partner must make at least four attempts at sexual
intercourse on four separate days during the untreated baseline period (according to
the answer to the following question in the Patient Diary: "Was sexual activity
initiated with the intention of intercourse?").
- At least 50% of attempts at sexual intercourse during the untreated baseline period
must be unsuccessful, according to the following questions from the subject diary (at
least one question should be answered "No"): "Were you able to achieve at least some
erection (some enlargement of the penis)?"; "Were you able to insert your penis in
your partner's vagina?"; "Did your erection last long enough for you to have
successful intercourse?".
Exclusion Criteria:
A) Previous or current medical conditions
- Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of
the Investigator is likely to affect the subject's ability to complete the study or
precludes the subject's participation in the study.
- Presence of penile anatomical abnormalities (e. g. penile fibrosis or Peyronie's
disease) which, in the Investigator's opinion, would significantly impair erectile
function.
- Primary hypoactive sexual desire.
- Spinal cord injury.
- History of surgical prostatectomy (excluding TURP).
- Retinitis pigmentosa.
- Unstable angina pectoris.
- History of myocardial infarction, stroke or life-threatening arrhythmia within the
prior 6 months.
- Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate
≥ 100 bpm).
- Severe chronic or acute liver disease, history of moderate or severe hepatic
impairment.
- Clinically significant chronic haematological disease which may lead to priapism such
as sickle cell anemia and leukemia.
- Bleeding disorder.
- Significant active peptic ulcer disease.
- Resting hypotension (a resting systolic blood pressure of < 90 mm Hg) or hypertension
(a resting systolic blood pressure > 170 mm Hg or a resting diastolic blood pressure >
110 mm Hg).
- History of malignancy within the past 5 years (other than squamous or basal cell skin
cancer).
- NYHA Class III and IV heart failure.
- History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C.
- Symptomatic postural hypotension within 6 months of visit 1. B) Concomitant
medication
- Subjects who are taking nitrates or nitric oxide donors.
- Subjects who take anticoagulants, except for antiplatelet agents.
- Subjects who are taking androgens.
- Subjects who are taking anti-androgens.
- Subjects who are taking the following inhibitors of cytochrome P450 3A4: very potent
HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole
and ketoconazole (topical forms are allowed) or erythromycin.
- Subjects who have received any investigational drug (including placebo) within 30 days
of Visit 1.
- Use of any treatment for ED within 7 days of visit 1 or during the study, including
oral medications, vacuum devices, constrictive devices, injections or urethral
suppositories.
- Subjects who are taking alpha blockers C) Abnormal laboratory values
- Subjects who have a serum total testosterone level more than 25% below the
age-adjusted lower limit of normal according to the range of the testing laboratory.
- Subjects with a serum creatinine > 3. 0 mg/dl.
- Elevation of AST and/or ALT > 3 times the upper limit of normal.
- Diabetic subjects with an HbA1c>12%.
Other Exclusion Criteria:
- Subjects age 65 or older who in the judgment of the investigator can not be started on
a 10 mg dose
- Subjects with a history of unresponsiveness to any PDE 5 Inhibitor treatment due to
lack of efficacy or significant side effects leading to discontinuation of the PDE 5
Inhibitor treatment.
- Subjects unwilling to cease use of vacuum devices, intracavernosal injections, Viagra®
or other therapy for ED during the study.
- Unwillingness of the subject or his partner to make 4 attempts at sexual intercourse
on four separate days during the untreated baseline period.
- Subjects with known hypersensitivity to Vardenafil, Bay 38-9456 (also known as
SB-782528) or any component of the investigational medication.
- Subjects who are illiterate or unable to understand the questionnaires or the Patient
Diary.
- Partners who are illiterate or unable to understand the questionnaires.
- Subjects who are unwilling or unable to complete the Patient Diary.
- Subjects or partners who, in the opinion of the investigator, would be non-compliant
with the visit schedule of study procedures.
- Subjects unwilling to refrain from consuming grapefruit juice or products containing
grapefruit juice with study medication (Canada only).
Locations and Contacts
Victoria V8T 5G1, Canada
Calgary, Alberta T2V 4R6, Canada
Phoenix, Arizona 85023, United States
Beverly Hills, California 90212, United States
Newport Beach, California 92660, United States
San Diego, California 92101, United States
Irvine, California 92618-3603, United States
San Bernardino, California 92404, United States
San Diego, California 92128, United States
Trumbull, Connecticut 06611, United States
Jacksonville, Florida 32257, United States
Riverdale, Georgia 30274, United States
Greenbelt, Maryland 20770, United States
Lutherville, Maryland 21093, United States
New Brunswick, New Jersey 08901, United States
Lawrenceville, New Jersey 08648, United States
New York, New York 10016, United States
Wilmington, North Carolina 28412, United States
Statesville, North Carolina 28677, United States
Charlotte, North Carolina 28209, United States
London, Ontario N6A 4V2, Canada
Oakville, Ontario L6H 3P1, Canada
Kitchener, Ontario N2M 5N4, Canada
Burlington, Ontario L7N 3V2, Canada
Barrie, Ontario L4M 4S5, Canada
Saskatoon, Saskatchewan S7M 0Z9, Canada
Additional Information
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Starting date: October 2003
Ending date: August 2004
Last updated: April 16, 2008
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