Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction

This study has been terminated.
(This prodect will be transferred to another company.)
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea Identifier:
First received: February 28, 2013
Last updated: November 30, 2015
Last verified: November 2015
The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction.

Condition Intervention Phase
Erectile Dysfunction
Drug: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Bravonto in Korea

Resource links provided by NLM:

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 4 weeks ]

Secondary Outcome Measures:
  • International Index of Erectile Function [ Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12 ]
    The International Index of Erectile Function is used for the assessment of erectile dysfunction, with scores ranging from 0 to 30. Evaluation of points are as follows: 1-10 = severe erectile dysfunction, 11-16 = moderate dysfunction, 17-21 = mild to moderate dysfunction, 22-25 = mild dysfunction, 26-30 = no dysfunction. Lower scores indicate worsening.

  • Sexual Encounter Profile [ Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12 ]
    The Sexual Encounter Profile is assessed after each sexual attempt consisting of a series of yes/no questions regarding specific aspects of each encounter. Question 1 asks, "Were you able to insert your penis into your partner's vagina?" and question 2 asks, "Did your erection last long enough for you to complete intercourse with ejaculation?".

  • Global assessment Questionnaire [ Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12 ]
    The Global Assessment Questionnaire is a self-administered questionnaire (Yes/No) that allows men to rate improvement in erectile function. Question 1 asks "Has the treatment you have been taking over the past 4 weeks improved your erections?" and if the answer is yes, question 2 then asks "Has the treatment improved your ability to engage in sexual activity"

  • Number of participants with adverse events [ Time Frame: Up to 12 weeks ]

Enrollment: 379
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mirodenafil Drug: No intervention
This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.

Detailed Description:
This is a non randomized (the study medication is not assigned by chance), open-label (all participants and study staff know the identity of the treatment), multi-center, prospective (looking forward using observations collected following participant enrollment), and non-comparative study in which participants with erectile dysfunction will be observed to evaluate the safety and effectiveness of mirodenafil for 12 weeks. Safety evaluations will include assessment of adverse events, and record of concomitant medications. The study will be conducted in Korea.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with erectile dysfunction and prescribed mirodenafil on demand.

Inclusion Criteria:

  • Participants diagnosed with erectile dysfunction
  • Participants prescribed mirodenafil on demand

Exclusion Criteria:

- Participants who have administered mirodenafil for other than an approved indication

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01802359

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

Responsible Party: Janssen Korea, Ltd., Korea Identifier: NCT01802359     History of Changes
Other Study ID Numbers: CR100836
MIRODENEDY4002 ( Other Identifier: Janssen Korea, Ltd., Korea )
MIR-KOR-PMS ( Other Identifier: Janssen Korea, Ltd., Korea )
Study First Received: February 28, 2013
Last Updated: November 30, 2015

Keywords provided by Janssen Korea, Ltd., Korea:
Erectile dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017