Study Stopped
This prodect will be transferred to another company.
A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction
Post-Marketing Surveillance of Bravonto in Korea
3 other identifiers
observational
379
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2011
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2012
CompletedFirst Submitted
Initial submission to the registry
February 28, 2013
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedJune 22, 2017
June 1, 2017
7 months
February 28, 2013
June 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
Up to 4 weeks
Secondary Outcomes (4)
International Index of Erectile Function
Baseline (Week 0), Week 4, Week 8, and Week 12
Sexual Encounter Profile
Baseline (Week 0), Week 4, Week 8, and Week 12
Global assessment Questionnaire
Baseline (Week 0), Week 4, Week 8, and Week 12
Number of participants with adverse events
Up to 12 weeks
Study Arms (1)
Mirodenafil
Interventions
This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.
Eligibility Criteria
Participants diagnosed with erectile dysfunction and prescribed mirodenafil on demand.
You may qualify if:
- Participants diagnosed with erectile dysfunction
- Participants prescribed mirodenafil on demand
You may not qualify if:
- \- Participants who have administered mirodenafil for other than an approved indication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Korea, Ltd., Korea Clinical Trial
Janssen Korea, Ltd., Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2013
First Posted
March 1, 2013
Study Start
November 7, 2011
Primary Completion
May 31, 2012
Study Completion
May 31, 2012
Last Updated
June 22, 2017
Record last verified: 2017-06