Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
Information source: Bayer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug); Levitra (Vardenafil, BAY38-9456) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
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) - a Fixed-Dose, Double-Blind, Randomized Multi-Center Trial - POTENT I
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: International Index of Erectile Function IIEF - EF Domain score at visit 4 (week 12) or LOCF (Last Observation Carried Forward)Sexual Encounter Profile, Question 2 (SEP 2) (success rates of penetration) at Visit 4 (Week 12) overall SEP 3 (maintenance of erection) at Visit 4 (Week 12) overall
Secondary outcome: Percentage of subjects achieving "back to normal" erectile function (IIEF-EF > / = 26) at visit 4 (week 12) or LOCF;All diary questions other than SEP 2 and 3 concerning erectile function administered over the entire treatment period; Number of sexual attempts under medication till first successful attempt (SEP 3) Treatment Satisfaction Scale (TSS) to be administered at the randomization visit and the final visit (or at Premature Discontinuation). A Global Assessment Question (GAQ) concerning the overall effect on erectile function to be administered at the final visit only. Safety laboratory examinations, vital signs, physical examination, ECG, and adverse event monitoring Pharmacokinetics in a subset of 24 subjects
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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 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, 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
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
BRUXELLES - BRUSSEL 1070, Belgium; Not yet recruiting
LIEGE 4000, Belgium; Recruiting
BRUXELLES - BRUSSEL 1200, Belgium; Not yet recruiting
GENT 9000, Belgium; Recruiting
BRUXELLES - BRUSSEL 1000, Belgium; Recruiting
GENK 3600, Belgium; Recruiting
ANTWERPEN 2020, Belgium; Not yet recruiting
MARSEILLE 13006, France; Recruiting
MARSEILLE 13009, France; Recruiting
LYON 69000, France; Recruiting
LILLE 59000, France; Recruiting
LYON CEDEX 69437, France; Recruiting
MONT-DE-MARSAN 40000, France; Recruiting
PARIS 75008, France; Recruiting
NIJVERDAL 7442 LS, Netherlands; Recruiting
ARNHEM 6836 BH, Netherlands; Recruiting
LOSSER 7581 BV, Netherlands; Recruiting
Deurne 5751 XJ, Netherlands; Recruiting
LEIDEN 2316 ZL, Netherlands; Recruiting
Pretoria 0083, South Africa; Recruiting
Alicante 03010, Spain; Not yet recruiting
Barcelona 08003, Spain; Recruiting
Barcelona 08034, Spain; Not yet recruiting
Valencia 46010, Spain; Not yet recruiting
Weiden, Bayern / 280 92637, Germany; Not yet recruiting
München, Bayern / 280 81925, Germany; Recruiting
Johannesburg, Gauteng 1818, South Africa; Recruiting
Johannesburg, Gauteng 2198, South Africa; Recruiting
Centurion, Gauteng 0140, South Africa; Recruiting
Krugersdorp, Gauteng 1739, South Africa; Recruiting
Pretoria, Gauteng 0001, South Africa; Recruiting
Hamburg, Hamburg / 287 20251, Germany; Recruiting
Hamburg, Hamburg / 287 20354, Germany; Recruiting
Durban, KwaZulu Natal 4091, South Africa; Recruiting
Durban, KwaZulu Natal 4037, South Africa; Recruiting
Durban, Kwazulu Natal 4001, South Africa; Recruiting
Osnabrück, Niedersachsen / 293 49076, Germany; Recruiting
Mülheim, Nordrhein-Westfalen / 481 45468, Germany; Recruiting
Mönchengladbach, Nordrhein-Westfalen / 618 41063, Germany; Recruiting
Vigo, Pontevedra 36211, Spain; Recruiting
Leipzig, Sachsen / 313 04109, Germany; Recruiting
Bautzen, Sachsen / 313 02625, Germany; Recruiting
Meißen, Sachsen / 313 01662, Germany; Recruiting
La Laguna, Tenerife 38320, Spain; Recruiting
Cape Town, Western Cape 7463, South Africa; Recruiting
Cape Town, Western Cape 7530, South Africa; Recruiting
Additional Information
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Starting date: April 2008
Ending date: March 2009
Last updated: October 28, 2008
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