Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10... | NCT00663130

Studies
Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

NCT00663130

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 11, 2013Estimated

Enrollment

759Actual

Phase

Phase 4

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)
Tadalafil

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

Oct 2013

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

Apr 2004

Primary Completion Date

Jul 2004Actual

Completion Date

Jul 2004Actual

First Submitted Date

Apr 17, 2008

First Submission Date that Met QC Criteria

Apr 17, 2008

First Posted Date

Apr 22, 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

Oct 9, 2013

Last Update Posted Date

Oct 11, 2013Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

Brief Summary

Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe 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

759Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Levitra (Vardenafil, BAY38-9456)
Arm 2	Active Comparator		Drug: Tadalafil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levitra (Vardenafil, BAY38-9456)	Drug	Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sexual Encounter Profile Question 3 (SEP-3)		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Sexual Encounter Profile Question 2 (SEP-2)		4 weeks
International Index of Erectile Function		4 weeks
Global Confidence Question (GCQ)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 64 years
Heterosexual males
Erectile dysfunction for more than 6 months

Exclusion Criteria:

Penile anatomical abnormalities
Spinal cord injury
History of surgical prostatectomy

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

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
D000068581	Tadalafil

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided