NCT01215409

Brief Summary

In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

9 months

First QC Date

September 28, 2010

Last Update Submit

May 16, 2014

Conditions

Erectile Dysfunction

Keywords

LevitraErectile dysfunctionTaiwan

Outcome Measures

Primary Outcomes (1)

  • General assessment of patients concerning efficacy and tolerability of vardenafil treatment

    2 months

Secondary Outcomes (4)

  • Time to first intercourse after intake of vardenafil

    2 months

  • Percentage of successful second intercourse within 24 hours

    2 months

  • Percentage of participants who are willing to continue treatment

    2 months

  • Number of participants with adverse events

    2 months

Study Arms (1)

Group 1

Drug: Vardenafil (Levitra, BAY38-9456)

Interventions

Vardenafil (Levitra, BAY38-9456)DRUG

5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months

Group 1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinics

You may qualify if:

  • Any adult patient (\>/=18 years) with erectile dysfunction treated with LEVITRA®.
  • Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Taiwan

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
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2010

First Posted

October 6, 2010

Study Start

February 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 19, 2014

Record last verified: 2014-05

Locations

TW(1)