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Completed

NCT Number: NCT00631969

Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males 18 years-of-age or older
  • Stable, heterosexual relationship for at least 6 months
  • A history of erectile dysfunction (ED) for at least 6 months

Exclusion criteria

  • Any underlying cardiovascular condition, including unstable angina pectoris
  • History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
  • Uncontrolled atrial fibrillation / flutter at screening
  • History of surgical prostatectomy for prostate cancer
  • Hereditary degenerative retinal disorders
  • History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
  • Presence of penile anatomical abnormalities
  • Subjects who have been confirmed with phenylketonuria (PKU)
  • Spinal cord injury
  • Resting or postural hypotension or hypertension
  • Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
  • Use of any treatment for ED within 7 days of Visit 1
  • History of congenital QT prolongation
  • History of syncope within the last 6 months prior to entry into the study

Treatment and study plan

Vardenafil ODT (STAXYN, BAY38-9456)

Drug

Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)

Placebo

Drug

Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Primary outcomes

  1. Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF

    Time frame: from baseline up to 12 weeks

    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').

  2. Change in Percentage From Baseline in Success of Penetration at 12 Weeks

    Time frame: from baseline up to 12 weeks of treatment

    Sexual encounter profile (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 penetrate the partner.

  3. 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.

Secondary outcomes

  1. 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').

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Number of Sexual Attempts Till First Successful Attempt

    Time frame: up to 12 weeks of treatment

  7. 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 scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.

  8. 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 scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference.

  9. 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 scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference.

  10. 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 scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference.

  11. 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 scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference.

  12. Satisfaction With Medication at Week 12 or LOCF

    Time frame: up to 12 weeks

    Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with medication" at LOCF expressed as the least square mean difference.

  13. Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale

    Time frame: up to 12 weeks of treatment

    Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)

  14. Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma

    Time frame: Visit 5 after 12 weeks of treatment

    Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

  15. Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma

    Time frame: Visit 5 after 12 weeks of treatment

    Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

  16. Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma

    Time frame: Visit 5 after 12 weeks of treatment

    Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

  17. Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma

    Time frame: Visit 5 after 12 weeks of treatment

    Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • GlaxoSmithKline
  • Schering-Plough

Registry information

Official study 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) - a Fixed-dose, Double-blind, Randomized Multi-center Trial - POTENT I

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 10, 2008
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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