Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction - Full Text View

Sponsor:	Bayer
Collaborators:	GlaxoSmithKline Schering-Plough
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00631969

Purpose

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.

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

International Index of Erectile Function IIEF - EF Domain score at visit 4 (week 12) or LOCF (Last Observation Carried Forward) [ Time Frame: Between visit 2 and visit 4 (12 weeks) ] [ Designated as safety issue: No ]
Sexual Encounter Profile, Question 2 (SEP 2) (success rates of penetration) at Visit 4 (Week 12) overall [ Time Frame: Between visit 2 and visit 4 (12 weeks) ] [ Designated as safety issue: No ]
SEP 3 (maintenance of erection) at Visit 4 (Week 12) overall [ Time Frame: Between visit 2 and visit 4 (12 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects achieving "back to normal" erectile function (IIEF-EF > / = 26) at visit 4 (week 12) or LOCF; [ Time Frame: At week 12 ] [ Designated as safety issue: No ]
All diary questions other than SEP 2 and 3 concerning erectile function administered over the entire treatment period; [ Time Frame: At week 0, 4 and 12 ] [ Designated as safety issue: No ]
Number of sexual attempts under medication till first successful attempt (SEP 3) [ Time Frame: Week -4 to Week 12 ] [ Designated as safety issue: No ]
Treatment Satisfaction Scale (TSS) to be administered at the randomization visit and the final visit (or at Premature Discontinuation). [ Time Frame: At week 0 and 12 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Safety laboratory examinations, vital signs, physical examination, ECG, and adverse event monitoring [ Time Frame: At week - 4, 0, 4 and 12, in addition AE monitoring from time of Informed Consent to 48 hours after last tablet (16 or 17 weeks approx.) ] [ Designated as safety issue: Yes ]
Pharmacokinetics in a subset of 24 subjects [ Time Frame: 48 to 168 hours after week 12 ] [ Designated as safety issue: Yes ]

Enrollment:	346
Study Start Date:	April 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) Subjects will receive 12 weeks of PRN treatment with vardenafil 10 mg ODT or matching placebo ODT
Arm 2: Placebo Comparator	Drug: Placebo Subjects will receive 12 weeks of PRN treatment with vardenafil 10 mg ODT or matching placebo ODT
Arm 3: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) After completion of Arm 1 and 2, a subset of subjects (24) will receive one dose of vardenafil 10 mg ODT, after which samples for pharmacokinetics will be taken between 0 and 24 hours

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631969

Show 48 Study Locations

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Schering-Plough

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	12093, Eudra CT- 2008-000536-40
Study First Received:	February 29, 2008
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00631969 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration

Keywords provided by Bayer:

Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010