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

NCT ID: NCT00665054

Last Updated: 2014-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Vardenafil Erectile dysfunction SSES-E (sexual self-efficacy scale - erectile function)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo tablets orally prior to sexual activity

Interventions

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Levitra (Vardenafil, BAY38-9456)

5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity

Intervention Type DRUG

Placebo

Matching placebo tablets orally prior to sexual activity

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Adana, , Turkey (Türkiye)

Site Status

Ankara, , Turkey (Türkiye)

Site Status

Ankara, , Turkey (Türkiye)

Site Status

Antalya, , Turkey (Türkiye)

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

Izmir, , Turkey (Türkiye)

Site Status

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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11382

Identifier Type: -

Identifier Source: org_study_id