Trials / Terminated
TerminatedNCT01802359
A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction
Post-Marketing Surveillance of Bravonto in Korea
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 379 (actual)
- Sponsor
- Janssen Korea, Ltd., Korea · Industry
- Sex
- Male
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | No intervention | This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed. |
Timeline
- Start date
- 2011-11-07
- Primary completion
- 2012-05-31
- Completion
- 2012-05-31
- First posted
- 2013-03-01
- Last updated
- 2017-06-22
Source: ClinicalTrials.gov record NCT01802359. Inclusion in this directory is not an endorsement.