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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00665054
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 160
• Locations: 8
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 20
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456); Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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.
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Aug 1, 2005
• Actual Study Completion Date: Aug 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. LOCF improved compared to baseline GAQ results at the end of the study [baseline versus visit 2 visit 5 or premature termination visit]

Secondary Outcome Measures

1. IIEF scores [visits 3, 4 and 5]

2. OF, SD, IS scores in IIEF Questionnaire [visits 2, 3, 4, 5 or at premature termination visit]

3. Scores of all individual questions on IIEF questionnaire [visits 2, 3, 4, 5 or at premature termination visit]

4. Subject's diary response [baseline and after randomization per visit period]

5. SSES-E scores [visits 2 and 5 or premature termination visit]

6. Summary score from the responses to SSES-E [visits 2 and 5 or premature termination visit]

7. Response scores and summary score from the responses to the SF-36 [visits 2 and 5 or premature termination visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Adana		Turkey	01330
2		Ankara		Turkey	06100
3		Ankara		Turkey	06500
4		Antalya		Turkey	07003
5		Istanbul		Turkey	34098
6		Istanbul		Turkey	34662
7		Izmir		Turkey	35340
8		Samsun		Turkey	55139

Sponsors and Collaborators

• Bayer
• GlaxoSmithKline

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00665054
• Other Study ID Numbers: 11382
• First Posted: Apr 23, 2008
• Last Update Posted: Dec 25, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Bayer: Vardenafil; Erectile dysfunction; SSES-E (sexual self-efficacy scale - erectile function)
• Additional relevant MeSH terms: Erectile Dysfunction; Vardenafil Dihydrochloride

Study Results

No Results Posted as of Dec 25, 2014