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.)
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01802359
First received: February 28, 2013
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • International Index of Erectile Function [ Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders 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.

Criteria

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 ClinicalTrials.gov identifier: NCT01802359

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

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01802359     History of Changes
Other Study ID Numbers: CR100836, MIRODENEDY4002, MIR-KOR-PMS
Study First Received: February 28, 2013
Last Updated: May 27, 2013
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Mirodenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014