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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00665496
First received: April 23, 2008
Last updated: October 10, 2013
Last verified: October 2013
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00665496     History of Changes
Other Study ID Numbers: 100492, ONTIME
Study First Received: April 23, 2008
Last Updated: October 10, 2013
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
Urological Agents

ClinicalTrials.gov processed this record on August 28, 2014