Clinical Trial: Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

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

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy and Safety of Tadalafil (LY450190) Once a Day in Subjects With Erectile Dysfunction W

Brief Summary: The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.

Detailed Summary:
Sponsor: Eli Lilly and Company

Current Primary Outcome:

  • Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.
  • Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses [ Time Frame: Baseline, Week 12 ]
    Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per participant.
  • Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses [ Time Frame: Baseline, 12 weeks ]
    Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per participant.


Original Primary Outcome:

  • Change in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) from baseline to endpoint [ Time Frame: 12 weeks ]
  • Change in Question 2 of the patient Sexual Encounter Profile (SEP) diary from baseline to endpoint [ Time Frame: 12 weeks ]
  • Change in Question 3 of the patient Sexual Encounter Profile (SEP) diary from baseline to endpoint. [ Time Frame: 12 weeks ]


Current Secondary Outcome:

  • Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night [ Time Frame: Baseline, Week 12 ]
    NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded.
  • Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night [ Time Frame: Baseline, Week 12 ]
    NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.
  • Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change [ Time Frame: Baseline, Week 12 ]
    NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12.
  • Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary [ Time Frame: Baseline, 12 weeks ]
    The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed.
  • The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint [ Time Frame: Week 12 ]
    The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).
  • Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire [ Time Frame: Baseline, Week 12 ]
    SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.
  • Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) [ Time Frame: Baseline, Week 12 ]
    Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.
  • Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) [ Time Frame: Baseline, 12 weeks ]
    Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.
  • Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) [ Time Frame: Baseline, Week 12 ]
    Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
  • Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) [ Time Frame: Baseline, 12 weeks ]
    Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
  • Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses [ Time Frame: Baseline, 12 weeks ]
    Assessed was the mean change from baseline in the percent

    Original Secondary Outcome:

    • Nocturnal Penile Tumescence (NPT) pattern, measured using electrobioimpedance volumetric assessment (NEVA device). [ Time Frame: Baseline, Week 12; Week 14 ]
    • The frequency of spontaneous morning erections by patient diary. [ Time Frame: Baseline; Week 4 , Week 8 ,Week12 ,Week 14 ]
    • The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire [ Time Frame: Week 12 ]
    • The Self-Esteem and Relationship (SEAR) questionnaire. [ Time Frame: Baseline, Week 12 ]
    • International Index of Erectile Function (IIEF), Orgasmic Functions; [ Time Frame: 12 weeks ]
    • International Index of Erectile Function (IIEF), Sexual Desire; [ Time Frame: 12 weeks ]
    • International Index of Erectile Function (IIEF), Intercourse satisfaction [ Time Frame: 12 weeks ]
    • International Index of Erectile Function (IIEF), overall satisfaction [ Time Frame: 12 weeks ]
    • Sexual Encounter Profile (SEP) question 1 percentage of "yes" responses [ Time Frame: 12 weeks ]
    • Sexual Encounter Profile (SEP) question 4 percentage of "yes" responses [ Time Frame: 12 weeks ]
    • Sexual Encounter Profile (SEP) question 5 percentage of "yes" responses [ Time Frame: 12 weeks ]
    • Global Assessment Question (GAQ) Question 1 [ Time Frame: Week 12 ]
    • Global Assessment Question GAQ question 2 [ Time Frame: Week 12 ]


    Information By: Eli Lilly and Company

    Dates:
    Date Received: February 2, 2009
    Date Started: January 2009
    Date Completion:
    Last Updated: December 15, 2010
    Last Verified: December 2010