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

Erectile Dysfunction Clinical Trial

Official title:

Post-Marketing Surveillance of Bravonto in Korea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01802359
• Other study ID #: CR100836
• Secondary ID: MIRODENEDY4002MI
• Status: Terminated
• Phase: N/A
• First received: February 28, 2013
• Last updated: June 21, 2017
• Start date: November 7, 2011
• Est. completion date: May 31, 2012

Study information

• Verified date: June 2017
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 379
• Est. completion date: May 31, 2012
• Est. primary completion date: May 31, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• No intervention
This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Up to 4 weeks
Secondary	International Index of Erectile Function	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.	Baseline (Week 0), Week 4, Week 8, and Week 12
Secondary	Sexual Encounter Profile	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?".	Baseline (Week 0), Week 4, Week 8, and Week 12
Secondary	Global assessment Questionnaire	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"	Baseline (Week 0), Week 4, Week 8, and Week 12
Secondary	Number of participants with adverse events		Up to 12 weeks