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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erectile Dysfunction

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: LOCF improved compared to baseline GAQ results at the end of the study

Secondary outcome:

IIEF scores

OF, SD, IS scores in IIEF Questionnaire

Scores of all individual questions on IIEF questionnaire

Subject's diary response

SSES-E scores

Summary score from the responses to SSES-E

Response scores and summary score from the responses to the SF-36

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Male.

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).

Locations and Contacts

Adana 01330, Turkey

Ankara 06100, Turkey

Ankara 06500, Turkey

Antalya 07003, Turkey

Istanbul 34098, Turkey

Istanbul 34662, Turkey

Izmir 35340, Turkey

Samsun 55139, Turkey

Additional Information

Click here and search for drug information provided by the FDA.

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Click here to find results for studies related to Bayer Healthcare products.

Starting date: August 2004
Last updated: December 23, 2014

Page last updated: August 23, 2015

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