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

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ClinicalTrials.gov Identifier: NCT01802359
Recruitment Status : Terminated (This prodect will be transferred to another company.)
First Posted : March 1, 2013
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction.

Condition or disease Intervention/treatment
Erectile Dysfunction Drug: No intervention

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.

Study Type : Observational
Actual Enrollment : 379 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Bravonto in Korea
Actual Study Start Date : November 7, 2011
Actual Primary Completion Date : May 31, 2012
Actual Study Completion Date : May 31, 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Mirodenafil Drug: No intervention
This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.



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

Secondary Outcome Measures :
  1. 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.

  2. 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?".

  3. 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"

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


Information from the National Library of Medicine

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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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802359


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

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov 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 )
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Device Product: No

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
Mental Disorders
Mirodenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action