Clinical Trial: Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.

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

Official Title: Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED)

Brief Summary: This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome:

  • Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) [ Time Frame: from baseline up to 12 weeks ]
    The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED'.)
  • Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks [ Time Frame: from baseline up to 12 weeks of treatment ]
    SEP (Sexual Encounter Profile) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.
  • Change From Baseline in Success of Erection Maintenance at 12 Weeks [ Time Frame: from baseline up to 12 weeks of treatment ]
    SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.


Original Primary Outcome: Positive change in IIEF-EF domain scores. Statistically significant simultaneous change from baseline for both SEP-2, and SEP-3 [ Time Frame: at week 0, 4, 12 ]

Current Secondary Outcome:

  • Percentage of Subjects Achieving "Back to Normal" Erectile Function [ Time Frame: up to 12 weeks of treatment ]
    Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').
  • Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks [ Time Frame: from baseline up to 12 weeks of treatment ]
    SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.
  • Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks [ Time Frame: from baseline up to 12 weeks of treatment ]
    SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.
  • Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks [ Time Frame: from baseline up to 12 weeks of treatment ]
    SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.
  • Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks [ Time Frame: from baseline up to 12 weeks of treatment ]
    SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.
  • Number of Sexual Attempts Till First Successful Attempt [ Time Frame: up to 12 weeks of treatment ]
  • Change From Baseline in Ease With Erection at 12 Weeks or LOCF [ Time Frame: from baseline up to 12 weeks ]
    Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.
  • Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF [ Time Frame: from baseline up to 12 weeks ]
    Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference
  • Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF [ Time Frame: from baseline up to 12 weeks ]
    Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference
  • Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF [ Time Frame: from baseline up to 12 weeks ]
    Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference
  • Change From Baseline in Confidence for Completion at 12 Weeks or LOCF [ Time Frame: from baseline up to 12 weeks ]
    Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with

    Original Secondary Outcome:

    • Percentage of subjects achieving "back to normal" erectile function (IIEF-EF > / = 26) at visit 4 (week 12) or LOCF; [ Time Frame: at week 12 ]
    • All diary questions other than SEP 2 and 3 concerning erectile function administered over the entire treatment period; [ Time Frame: at week 0, 4, 12 ]
    • Treatment Satisfaction Scale (TSS) to be administered at the randomization visit and the final visit (or at Premature Discontinuation). [ Time Frame: at week 0, 12 ]
    • A Global Assessment Question (GAQ) concerning the overall effect on erectile function to be administered at the final visit only. [ Time Frame: at week 12 ]
    • Safety laboratory examinations, vital signs, physical examination, ECG, and adverse event monitoring [ Time Frame: at week - 4, 0, 4, 12 ]
    • AE monitoring from time of Informed Consent to 48 hours after last tablet (16 or 17 weeks approximately) [ Time Frame: at week - 4, 0, 4 and 12 ]


    Information By: Bayer

    Dates:
    Date Received: April 4, 2008
    Date Started: April 2008
    Date Completion:
    Last Updated: July 29, 2014
    Last Verified: July 2014