Clinical Trial: A Study in Patients With Erectile Dysfunction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Impact of Tadalafil (LY450190) Once a Day or Tadalafil on Demand Compared to Sildenafil Citrate on Demand on Treatment Discontinuation in Patients With Erectile Dysfunction

Brief Summary: The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.

Detailed Summary:
Sponsor: Eli Lilly and Company

Current Primary Outcome: Time to Discontinuation of Randomized Treatment [ Time Frame: Baseline up to 334 days ]

Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method.


Original Primary Outcome: Time to discontinuation of randomised treatment [ Time Frame: Through 24 weeks ]

Current Secondary Outcome:

  • Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain [ Time Frame: Baseline, 4, 8, 16, and 24 weeks ]
    Self-reported EF score over past 4 weeks. Items 1-5 scores range from 0 (no sexual activity) to 5 (high EF). Item 15 score ranges from 1 (very low confidence to get/keep erection) to 5 (very high confidence). Total scores range from 1 to 30; lower scores denote greater erectile dysfunction severity. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.
  • Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain [ Time Frame: Baseline, 4, 8, 16, and 24 weeks ]
    Self-reported orgasmic function on the IIEF over past 4 weeks and consists of 2 questions (items 9 and 10). Each question is rated on a scale from 0 (no sexual stimulation) to 5 (almost always/always). Total scores range from 0 to 10; lower scores represent lower orgasmic function. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.
  • Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain [ Time Frame: Baseline, 4, 8, 16, and 24 weeks ]
    Self-reported sexual desire on IIEF over past 4 weeks; comprises 2 questions (items 11 and 12). Each question rated on a scale from 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). Total scores range: 2 to 10; lower numerical scores denote lower sexual desire. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.
  • Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP) [ Time Frame: Baseline, 4, 8, 16, and 24 weeks ]
    Participant-assessed diary. Has 5 questions (Question[Q]1:erection achievement, Q2:successful penetration, Q3:successful intercourse, Q4:satisfied with erection, and Q5:satisfied with sexual experience) for each sexual encounter made over specified period of time. SEP Q1-Q5 scores determined as percentage of 'Yes' responses to each of 5 questions out of all sexual attempts recorded during the time period. Least Squares Mean changes from baseline to endpoint for each visit from a repeated measures analysis included terms for baseline score, treatment group, country, visit, and visit*treatment.
  • Global Assessment Questions (GAQ) [ Time Frame: 24 weeks ]
    The GAQ consists of 2 Yes/No/No Response (No Respo) questions. GAQ Question (Q)1: Has the treatment you have been taking during this study improved your erections? GAQ Q2: Has the treatment improved your ability to engage in sexual activity?
  • Number of Treatment Switches [ Time Frame: Baseline through 24 weeks ]
    The number of times participants switched erectile dysfunction medication within the 3 treatments being studied (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand).
  • Patterns of Erectile Dysfunction Treatment Change [ Time Frame: Baseline through 24 weeks ]
    Results are reported as the number of participants per sequence of study medications (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) that were taken as a result of switching treatments. The Other Treatment Sequence reports the number of participants per sequence of study medications that were taken as a result of switching treatments more than once. The number of participants who did not switch is also reported.
  • Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment [ Time Frame: Baseline through 24 weeks ]
    The reported reasons for a decision to discontinue from initial randomized treatment prior to Week 24 are reported. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered as switching of treatment.
  • Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments [ Time Frame: 8 weeks up to 334 days ]
    The differences in time between the 8-week time point and the discontinuation of all study treatments (that is, discontinuation from the study

    Original Secondary Outcome:

    • Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain [ Time Frame: Baseline to 4, 8, 16, and 24 weeks ]
    • Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain [ Time Frame: Baseline to 4, 8, 16 and 24 weeks ]
    • Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS) [ Time Frame: Baseline, 24 weeks ]
    • Number of Treatment Switches [ Time Frame: Baseline through 24 weeks ]
    • Patterns of Erectile Dysfunction Treatment Change [ Time Frame: Baseline through 24 weeks ]
    • Number of days from the 8-week study visit to the time the patient discontinues from all Phosphodiesterase type 5 inhibitor treatments [ Time Frame: 8 weeks to 24 weeks ]
    • Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP) [ Time Frame: Baseline to 4, 8, 16, and 24 weeks ]
    • Global Assessment Questions (GAQ) [ Time Frame: 24 weeks ]
    • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks [ Time Frame: 4, 8, 16, and 24 weeks ]
    • Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire [ Time Frame: Baseline to 4, 8, 16, and 24 weeks ]
    • Reasons for switch of Erectile Dysfunction treatment [ Time Frame: Baseline through 24 weeks ]
    • Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain [ Time Frame: Baseline to 4, 8, 16, and 24 weeks ]
    • Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain [ Time Frame: Baseline to 4, 8, 16, and 24 weeks ]
    • Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain [ Time Frame: Baseline to 4, 8, 16, and 24 weeks ]
    • Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire [ Time Frame: Baseline to 4, 8, 16, and 24 weeks ]
    • Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire [ Time Frame: Baseline to 4, 8, 16, and 24 weeks ]
    • Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire [ Time Frame: Baseline to 4, 8, 16, and 24 weeks ]


    Information By: Eli Lilly and Company

    Dates:
    Date Received: May 5, 2010
    Date Started: May 2010
    Date Completion:
    Last Updated: September 18, 2012
    Last Verified: September 2012