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

Terminated

• Conditions: Erectile Dysfunction
• Interventions: Drug: No intervention

• Registration Number: NCT01802359
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-11-07
• Primary Completion: 2012-05-31
• Study Completion: 2012-05-31
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 379

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mirodenafil	No intervention	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Global assessment Questionnaire	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"
International Index of Erectile Function	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	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?".
Number of participants with adverse events	Up to 12 weeks