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
Overview
- Phase
- Phase 4
- Intervention
- LEVITRA (vardenafil)
- Conditions
- Erectile Dysfunction
- Sponsor
- GlaxoSmithKline
- Enrollment
- 395
- Locations
- 1
- Primary Endpoint
- Mean success rates of maintenance based on attempts
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Levitra
10mg x 4 weeks, with option to increase to 20mg aat that time if desired
Intervention: LEVITRA (vardenafil)
placebo
Intervention: placebo
Outcomes
Primary Outcomes
Mean success rates of maintenance based on attempts
Time Frame: Up to Week 12
Success rate of maintenance was derived from the SEP Question 3 (SEP-3) of the participant's diary that asked 'Did your erection last long enough for you to have successful intercourse?'. Responses were either Yes or No. Participants were instructed to complete diary questions as soon as possible after each sexual attempt, but no later than 24 hours after the attempt. The per-participant overall success rate for maintenance was calculated by dividing the number of successful attempts (SEP-3=yes) over 12 weeks by the total number of valid attempts recorded over 12 weeks. If the participant was not able to make any valid attempts in 12 weeks, the participant was non-evaluable. Per-participant success rates were then averaged at the group level to obtain the mean success rate from Weeks 0-12.
Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)
Time Frame: Up to Week 12
The IIEF questionnaire is a validated 15-item instrument that assesses the participant's erectile function over the previous 4 weeks. The IIEF includes 5 domains affecting male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Responses to the IIEF were re-coded using a standard coding method, where more positive responses received a higher score. The EF domain score was calculated as the sum of the re-coded scores from questions 1-5 and 15, using last observation carried forward (LOCF). Scores range from 1 (lowest) to 30 (highest). If two or more items in the EF domain were missing, the EF domain score was considered to be missing.
Mean success rate of insertion based on attempts
Time Frame: Up to Week 12
Success rate of insertion was derived from the Sexual Encounter Profile (SEP) Question 2 (SEP-2) of the participant's diary that asked 'Were you able to insert your penis into your partner's vagina?'. Responses were either Yes or No. Patients were instructed to complete diary questions as soon as possible after each sexual attempt, but no later than 24 hours after the attempt. The per-participant overall success rate for insertion was calculated by dividing the number of successful attempts (SEP-2=yes) over 12 weeks by the total number of valid attempts recorded over 12 weeks. If the participant was not able to make any valid attempts in 12 weeks, the participant was non-evaluable. Per-participant success rates were then averaged at the group level to obtain the mean success rate from Weeks 0-12.
Secondary Outcomes
- Number of participants with response 'Yes' for Global Assessment Question(Up to Week 12)
- Change from Baseline in participant's diary results(Up to Week 12)
- Mean score for Keep It Simple (KIS) scale(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(Up to Week 12)
- Mean duration of erection regardless of SEP-3 Response(Up to Week 12)
- Change from Baseline in duration of erection leading to completion of successful intercourse.(Up to Week 12)
- Mean duration of erection leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 [SEP-3](Up to Week 12)
- Number of participants with normal erectile function having EF domain scores of 26 and above(Up to Week 12)