Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction
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.
1 other identifier
interventional
229
2 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2003
Shorter than P25 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 9, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedOctober 14, 2013
October 1, 2013
April 9, 2008
October 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Weeks 0 -12
Secondary Outcomes (8)
SEP3 at weeks 4 and 12 of treatment compared to placebo.
Weeks 4 and 12
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
Weeks 4, 8 and 12
Global assessment question (GAQ) at weeks 4 and 12 of treatment compared to placebo
Weeks 4 and 12
Global confidence question (GCQ) at 12 weeks of treatment compared to placebo.
Week 12
The score for the IIEF questionnaire EF domain (IIEF-EF) at weeks 4, 12, and LOCF of treatment compared to placebo
Weeks 4 and 12
- +3 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALInterventions
BAY 38-9456 (Vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
Identical placebo tablets will be matched for each vardenafil dosage and will be indistinguishable from active treatment
Eligibility Criteria
You may qualify if:
- 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?".
You may not qualify if:
- 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).
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- GlaxoSmithKlinecollaborator
Study Sites (26)
Unknown Facility
Phoenix, Arizona, 85023, United States
Unknown Facility
Beverly Hills, California, 90212, United States
Unknown Facility
Irvine, California, 92618-3603, United States
Unknown Facility
Newport Beach, California, 92660, United States
Unknown Facility
San Bernardino, California, 92404, United States
Unknown Facility
San Diego, California, 92101, United States
Unknown Facility
San Diego, California, 92128, United States
Unknown Facility
Trumbull, Connecticut, 06611, United States
Unknown Facility
Jacksonville, Florida, 32257, United States
Unknown Facility
Riverdale, Georgia, 30274, United States
Unknown Facility
Greenbelt, Maryland, 20770, United States
Unknown Facility
Lutherville, Maryland, 21093, United States
Unknown Facility
Lawrenceville, New Jersey, 08648, United States
Unknown Facility
New Brunswick, New Jersey, 08901, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Charlotte, North Carolina, 28209, United States
Unknown Facility
Statesville, North Carolina, 28677, United States
Unknown Facility
Wilmington, North Carolina, 28412, United States
Unknown Facility
Calgary, Alberta, T2V 4R6, Canada
Unknown Facility
Barrie, Ontario, L4M 4S5, Canada
Unknown Facility
Burlington, Ontario, L7N 3V2, Canada
Unknown Facility
Kitchener, Ontario, N2M 5N4, Canada
Unknown Facility
London, Ontario, N6A 4V2, Canada
Unknown Facility
Oakville, Ontario, L6H 3P1, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7M 0Z9, Canada
Unknown Facility
Victoria, V8T 5G1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2008
First Posted
April 14, 2008
Study Start
October 1, 2003
Study Completion
August 1, 2004
Last Updated
October 14, 2013
Record last verified: 2013-10