Last updated: 11/03/2018 09:08:26
A study evaluating vardenafil compared to placebo in subjects with erectile dysfunction (ED) and dyslipidemia
GSK study ID
106718
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, double-blind, placebo-controlled, parallel-group, study evaluating the efficacy, safety, and duration of erection of flexible-dose vardenafil administered for 12 weeks compared to placebo in subjects with erectile dysfunction and dyslipidemia
Trial description: This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects will be using a stopwatch to measure the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina. Next there are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to visit the clinic on 5 occasions over a period of 4 months.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)
Timeframe: Up to Week 12
Mean success rate of insertion based on attempts
Timeframe: Up to Week 12
Mean success rates of maintenance based on attempts
Timeframe: Up to Week 12
Secondary outcomes:
Mean duration of erection leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 [SEP-3]
Timeframe: Up to Week 12
Change from Baseline in scores for questions on the IIEF questionnaire and scores of the other non-EF domains of the IIEF
Timeframe: Baseline, Week 4, Week 8 and Week 12
Number of participants with normal erectile function having EF domain scores of 26 and above
Timeframe: Up to Week 12
Change from Baseline in participant's diary results
Timeframe: Up to Week 12
Mean duration of erection regardless of SEP-3 Response
Timeframe: Up to Week 12
Change from Baseline in duration of erection leading to completion of successful intercourse.
Timeframe: Baseline to Week 12
Number of participants with response 'Yes' for Global Assessment Question
Timeframe: Up to Week 12
Mean score for Keep It Simple (KIS) scale
Timeframe: Up to Week 12
Interventions:
Enrollment:
395
Primary completion date:
2007-17-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Erectile Dysfunction
Product
vardenafil
Collaborators
Not applicable
Study date(s)
May 2006 to May 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Male
Age
18 - 64 years
Accepts healthy volunteers
No
- Inclusion criteria:
- Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
- Stable heterosexual relationship for more than 6 months.
- The subject must make at least four attempts at sexual intercourse (according to the question in the subject diary: Was sexual activity initiated with the intention of intercourse?) on four separate days during the untreated baseline period. At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary [at least one question should be answered "No"]: Was participant able to achieve at least some erection (some enlargement of the penis)? Was participant able to insert penis into partner's vagina? Did participant's erection last long enough to have successful intercourse?
- Diagnosis of dyslipidemia treated with a stable dose of a statin for 6 months at Visit 1.
- IIEF-EF domain score of 25 denoting mild to severe ED at Visit 2.
- Documented, dated, written Informed Consent. Exclusion criteria:
- Premature ejaculator <2 minutes
- Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities, or substance abuse disorder that MD feels subject will not be able to complete the study.
- Low sexual desire.
- Prior prostatectomy surgery
- Severe chronic or acute liver disease, history of moderate or severe liver impairment
- Clinically significant chronic hematological disease
- Bleeding disorder or significant active peptic ulceration.
- Cardiovascular conditions that prevent sexual activity.
- History of heart attack, stroke, or life-threatening arrhythmia within the prior 6 months.
- hypotension or hypertension at rest.
- cancer within the past 5 years. Use of these medications: nitrates or nitric oxide donors, anti-androgens, oral or injectable androgens, received any investigational drug (including placebo) within 30 days of screening (Visit 1).
- Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
- Subjects who are taking the following potent inhibitors of cytochrome P-450 3A4.
- Abnormal Laboratory Values: 1. serum total testosterone level >25% below the lower limit of normal 2. serum creatinine >3.0 mg/dl. 3.AST and/or ALT >3x the upper limit of normal.
Trial location(s)
Location
GSK Investigational Site
Fort Myers, Florida, United States, 33916
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, North Carolina, United States, 28304
Status
Study Complete
Location
GSK Investigational Site
Concord, California, United States, 94520
Status
Study Complete
Showing 1 - 6 of 65 Results
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-17-05
Actual study completion date
2007-17-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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