Evaluating of the Efficacy and Safety of Vardenafil in Su... | NCT00662441

Studies
Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

NCT00662441

Sponsor

Bayer

Status

Completed

Last Update Posted

Jun 22, 2009Estimated

Enrollment

102Actual

Phase

Phase 4

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)

Countries

Not provided

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

Jun 2009

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

Sep 2003

Primary Completion Date

Not provided

Completion Date

Jun 2004Actual

First Submitted Date

Apr 16, 2008

First Submission Date that Met QC Criteria

Apr 18, 2008

First Posted Date

Apr 21, 2008Estimated

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

Jun 19, 2009

Last Update Posted Date

Jun 22, 2009Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

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

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levitra (Vardenafil, BAY38-9456)	Drug	10mg taken 1 hours before sexual intercourse	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
International Index of Erectile Function- Erectile Function domain		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Global Assessment Questionnaire (GAQ)		8 weeks
Safety and tolerability		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men >/= 18 years of age
Erectile Dysfunction

Exclusion Criteria:

History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
Nitrate therapy
Other exclusion criteria apply according to the Summary of Product Characteristics

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

Not provided

Sampling Method

Not provided

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