NCT00668135

Brief Summary

To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_4

Geographic Reach
6 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

April 25, 2008

Last Update Submit

December 15, 2014

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionVardenafil

Outcome Measures

Primary Outcomes (1)

  • International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)

    12 weeks

Secondary Outcomes (3)

  • Global Assessment Question

    12 weeks

  • Other diary responses

    12 weeks

  • Safety and tolerability

    12 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Vardenafil (Levitra, BAY38-9456)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Vardenafil (Levitra, BAY38-9456)DRUG

Vardenafil 10 mg orally on demand prior to intercourse

Arm 1
PlaceboDRUG

Matching placebo

Arm 2

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 20 years and older- Males with erectile dysfunction

You may not qualify if:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

Unknown Facility

Petlaing Jaya, Salangor, 47500, Malaysia

Location

Unknown Facility

Kuching, Sarawak, Malaysia

Location

Unknown Facility

Kuala Lumpur, 51200, Malaysia

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Manila, 150, Philippines

Location

Unknown Facility

Manila, Philippines

Location

Unknown Facility

Singapore, 119074, Singapore

Location

Unknown Facility

Singapore, 169608, Singapore

Location

Unknown Facility

Singapore, 529889, Singapore

Location

Unknown Facility

Bangkok, Bangkok, 10700, Thailand

Location

Unknown Facility

Bangkok, Bangkok, Thailand

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 29, 2008

Study Start

March 1, 2003

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

December 17, 2014

Record last verified: 2014-12

Locations

PH(2)HK(1)ID(1)MY(4)SG(3)TH(2)