Erectile DysfunctionNCT01802359
A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction
An observational study of Erectile Dysfunction, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- How many people
- 379 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2011to 31 May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with erectile dysfunction and prescribed mirodenafil on demand.
Who may be able to join
- Participants diagnosed with erectile dysfunction
- Participants prescribed mirodenafil on demand
Who cannot join
- Participants who have administered mirodenafil for other than an approved indication
About this study
Official title: Post-Marketing Surveillance of Bravonto in Korea
The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction.
Read the 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
- Erectile Dysfunction
- Being tested
- No intervention
- Keywords
- Erectile dysfunction, Mirodenafil, Bravonto
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Mirodenafil | Not described Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 4 weeks
Secondary outcomes (4)
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.
Measured: Baseline (Week 0), Week 4, Week 8, and Week 12
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?".
Measured: Baseline (Week 0), Week 4, Week 8, and Week 12
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"
Measured: Baseline (Week 0), Week 4, Week 8, and Week 12
Number of participants with adverse events
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study start7 Nov 2011
- Primary completion31 May 2012
- Study completion31 May 2012
Why it stopped: This prodect will be transferred to another company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802359
- Sponsor's protocol ID
- CR100836
- Other IDs
- MIRODENEDY4002, MIR-KOR-PMS
- Status last verified
- Jun 2017
- First submitted
- 28 Feb 2013
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Bravonto in Korea
- ClinicalTrials.gov ID
- NCT01802359
- Acronym / sponsor ID
- CR100836
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Mirodenafil, Bravonto
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This prodect will be transferred to another company.
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2011 (actual)
- Primary completion
- 31 May 2012 (actual)
- Study completion
- 31 May 2012 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirodenafil | – | Drug: No intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with erectile dysfunction and prescribed mirodenafil on demand.
Key inclusion criteria (2 listed)
- Participants diagnosed with erectile dysfunction
- Participants prescribed mirodenafil on demand
Key exclusion criteria (1 listed)
- Participants who have administered mirodenafil for other than an approved indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed. | Drug | Mirodenafil |
Primary outcome
Number of participants with adverse events
Time frame: Up to 4 weeks
4 secondary outcomes
International Index of Erectile Function
Time frame: Baseline (Week 0), Week 4, Week 8, and Week 12
Sexual Encounter Profile
Time frame: Baseline (Week 0), Week 4, Week 8, and Week 12
Global assessment Questionnaire
Time frame: Baseline (Week 0), Week 4, Week 8, and Week 12
Number of participants with adverse events
Time frame: Up to 12 weeks
Results and safety
The study was stopped early (reason given: This prodect will be transferred to another company.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Janssen Korea, Ltd., Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This prodect will be transferred to another company.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.