BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00665054
First received: April 18, 2008
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo


Condition Intervention Phase
Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multi-centre, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-esteem and Self Confidence in Subjects With Erectile Dysfunction.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • LOCF improved compared to baseline GAQ results at the end of the study [ Time Frame: baseline versus visit 2 visit 5 or premature termination visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IIEF scores [ Time Frame: visits 3, 4 and 5 ] [ Designated as safety issue: No ]
  • OF, SD, IS scores in IIEF Questionnaire [ Time Frame: visits 2, 3, 4, 5 or at premature termination visit ] [ Designated as safety issue: No ]
  • Scores of all individual questions on IIEF questionnaire [ Time Frame: visits 2, 3, 4, 5 or at premature termination visit ] [ Designated as safety issue: No ]
  • Subject's diary response [ Time Frame: baseline and after randomization per visit period ] [ Designated as safety issue: No ]
  • SSES-E scores [ Time Frame: visits 2 and 5 or premature termination visit ] [ Designated as safety issue: No ]
  • Summary score from the responses to SSES-E [ Time Frame: visits 2 and 5 or premature termination visit ] [ Designated as safety issue: No ]
  • Response scores and summary score from the responses to the SF-36 [ Time Frame: visits 2 and 5 or premature termination visit ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: August 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity
Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo tablets orally prior to sexual activity

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
  • At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion Criteria:

  • Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.
  • Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded).
  • Unstable angina pectoris.
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
  • Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate >100 BPM).
  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: NCT00665054

Locations
Turkey
Adana, Turkey, 01330
Ankara, Turkey, 06500
Ankara, Turkey, 06100
Antalya, Turkey, 07003
Istanbul, Turkey, 34098
Istanbul, Turkey, 34662
Izmir, Turkey, 35340
Samsun, Turkey, 55139
Sponsors and Collaborators
Bayer
GlaxoSmithKline
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00665054     History of Changes
Other Study ID Numbers: 11382
Study First Received: April 18, 2008
Last Updated: October 9, 2013
Health Authority: Turkey: Ethics Committee
Turkey: Ministry of Health

Keywords provided by Bayer:
Vardenafil
Erectile dysfunction
SSES-E (sexual self-efficacy scale - erectile function)

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 September 14, 2014