Vardenafil Treatment Of Erectile Dysfunction In Depressiv... | NCT00470873

Studies
Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men

NCT00470873

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 2, 2014Estimated

Enrollment

2,471Actual

Phase

Not provided

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Feb 2008Actual

First Submitted Date

May 7, 2007

First Submission Date that Met QC Criteria

May 7, 2007

First Posted Date

May 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2014

Last Update Posted Date

Dec 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. The secondary aim of this study is to assess the influence of the treatment with Levitra on self-esteem (depressive symptomology) in men with ED.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,471Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levitra (Vardenafil, BAY38-9456)	Drug	Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician		At the patients control visit (approx. 3 months from the initial)

Secondary Outcomes

Measure	Description	Time Frame
Influence of vardenafil on depressive symptoms and self-esteem measured with CES-D and Rosenberg scale		At the patients control visit (approx. 3 months from the initial)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18
Erectile dysfunction untreated or ineffectively treated with other than vardenafil PDE5 inhibitors

Exclusion Criteria:

Treatment with nitrates
Allergy to vardenafil or other tablets ingredients
Treatment with CYP3A4 inhibitors (e.g. indinavir, ritonavir, ketoconazole, itraconazole, erythromycin)
Cardiovascular status excluding any sexual activity

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069058	Vardenafil Dihydrochloride

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
LV0610PL
VALOR