Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004143

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004143
  •   2013/01/11
  •   2008/02/29
  •   no
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Secondary IDs

  •   2008-000536-40 
  •   NCT00631969  (ClinicalTrials.gov)
  •   12093  (Bayer)
  •   2008-000536-40 
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Health Condition or Problem studied

  •   Erectile Dysfunction
  •   N48.4 -  Impotence of organic origin
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Interventions/Observational Groups

  •   Drug: Vardenafil ODT (STAXYN, BAY38-9456)
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- 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').
- 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.
- 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.

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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 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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)
- 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.
- 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.
- 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.
- 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.

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Countries of Recruitment

  •   Belgium
  •   France
  •   Germany
  •   Netherlands
  •   South Africa
  •   Spain
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Locations of Recruitment

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Recruitment

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  •   2008/04/30
  •   362
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer
    • Bayer Study Director 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2009/01/01
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Trial Publications, Results and other Documents

  •   Click here and search for drug information provided by the FDA.
  •   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
  •   Debruyne FM, Gittelman M, Sperling H, Börner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30.; 21883954
  •   Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.; 20233275
  •   Heinig R, Weimann B, Dietrich H, Böttcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.; 20925442
  •   Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.; 20807322
  •   Click here to find results for studies related to Bayer Healthcare products.
  •   Click here and search for information of Bayer products for Europe
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.