A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00665496

Purpose

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-Center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction.

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3) [ Time Frame: First four doses with successful intercourse ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2). [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- The erectile function (EF) domain score of the International Index of Erectile Function (IIEF) calculated as the sum of scores from Questions 1-5 and 15 at Week 4 as well as all other IIEF factor subscores. [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration. [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- Other diary questions [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: within the study duration ] [ Designated as safety issue: Yes ]

Enrollment:	870
Study Start Date:	June 2003
Study Completion Date:	November 2003

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 10 mg and 20 mg orally once a day as needed
Placebo Comparator: Arm 2	Drug: Placebo Matching Placebo

Eligibility

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

Criteria

Inclusion Criteria:

Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
Heterosexual relationship
18 years and older

Exclusion Criteria:

Primary hypoactive sexual desire
History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months
Nitrates or nitric oxide donors use
Other exclusion criteria according to the US Product Information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665496

Show 75 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

#PL#J. SEX. MED. 1 (2) 168-178 (2004) , ISSN:1743-6095 This link exits the ClinicalTrials.gov site

#PL#PubMed. This link exits the ClinicalTrials.gov site

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00665496 History of Changes
Other Study ID Numbers:	100492, ONTIME
Study First Received:	April 23, 2008
Last Updated:	June 12, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil
Onset of action

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012