A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia
- Registration Number
- NCT00379756
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 395
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - Levitra LEVITRA (vardenafil) 10mg x 4 weeks, with option to increase to 20mg aat that time if desired
- Primary Outcome Measures
Name Time Method Mean success rates of maintenance based on attempts 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) 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 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 Outcome Measures
Name Time Method Number of participants with response 'Yes' for Global Assessment Question Up to Week 12 The participants were asked to complete the self-administered Global Assessment Question. The question asked was 'has the treatment you have been taking over the past 4 weeks improved your erections'. The response was either Yes or No depending on comparison to participant's erections before their participation in this study. For the scale missing values remained missing.
Change from Baseline in participant's diary results Up to Week 12 Electronic diaries were provided to participants. Participants were supposed to complete the diary questions as soon as possible after each sexual attempt but no later than 24 hours after the attempts. The diary questions (Ability to achieve at least some erection, Ability to insert penis into partner's vagina, Long enough erection having successful intercourse, Satisfied with the hardness of erection, Satisfied with this sexual experience, Ability to ejaculate) response rates were presented for Weeks 0-12. The Baseline was the value at Week 0. Change from Baseline was the post-Baseline value minus Baseline value.
Mean score for Keep It Simple (KIS) scale Up to Week 12 The KIS scale was a self-reported visual analog scale (VAS) from 0 to 10 designed to assess erections as 'how do you grade your erections over the last 4 weeks?'. For the scale missing values remained as missing.
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 Non-EF domains of the IIEF (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, Overall Satisfaction) and IIEF questions (Erection during sexual activity?, Hard enough for penetration?, Able to penetrate partner?, Maintain your erection?, Maintain to completion?, Times attempted intercourse, Satisfactory for you?, Enjoyed sexual intercourse?, How often did you ejaculate?, How often feeling of orgasm?, How often felt sexual desire?, Rate level of sexual desire?, How satisfied with sex life?, Satisfied with sexual relationship? and Confidence to get, keep erection?) scores were assessed at Week 4, Week 8 and Week 12. The Baseline was the value at Week 0. Change from Baseline was the post-Baseline value minus Baseline value.
Mean duration of erection regardless of SEP-3 Response Up to Week 12 Duration of erection was time from erection perceived hard enough for penetration (start stopwatch) until withdrawal from the partner's vagina (stop stopwatch) regardless of completion of successful intercourse. The data was presented for overall period from Week 0 to Week 12.
Change from Baseline in duration of erection leading to completion of successful intercourse. Up to Week 12 Duration of erection was time from erection perceived hard enough for penetration (start stopwatch) until withdrawal from the partner's vagina (stop stopwatch) leading to completion of successful intercourse. The data was presented for overall period from Week 0 to Week 12. The Baseline was the value at Week 0. Change from Baseline was the post-Baseline value minus Baseline value.
Mean duration of erection leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 [SEP-3] Up to Week 12 Duration of erection leading to completion of successful intercourse was derived from data recorded in the participant's diary. For each diary entry, the time from erection perceived hard enough for penetration until withdrawal from partner's vagina was measured by stopwatch and recorded in the participant's diary. For diary entries where SEP-3=yes, this recorded duration was used in calculations of a per-participant median duration. For diary entries where SEP-3=no, a duration of 0 was used to calculate the per-participant median. The per-participant median values averaged at the group level to obtain the mean duration of erection leading to completion of successful intercourse as measured by SEP-3.
Number of participants with normal erectile function having EF domain scores of 26 and above Up to Week 12 The EF domain score was calculated by summing recoded responses to Questions 1-5 and 15, for each participant. It ranged from 1 to 30. EF domain scores were dichotomized as either normal (26 and above) or below normal (below 26) using LOCF, to calculate number of participants returning to normal erectile function. For the EF domain score the total was considered to be missing if 2 or more answers in the domain were missing.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Milwaukee, Wisconsin, United States