Trial · NCT02916693
Mirabegron For Erectile Dysfunction
NCT02916693, Phase 1, Phase 2, Completed, Johns Hopkins University; results first posted 2021-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Mirabegron For Erectile Dysfunction. Trials, record NCT02916693. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02916693
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirabegron For Erectile Dysfunction
- NCT number
- NCT02916693
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Erectile Dysfunction, Overactive Bladder, Urinary Incontinence
- Interventions
- Mirabegron
- First posted
- 2016-09-27
- Last updated
- 2021-01-05
- Results first posted
- 2021-01-05
- Limitations and caveats
- Among the limitations of this study are the small number of subjects, short duration of therapy, and a single-arm design with no control group.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Erectile Function Assessed by IIEF Questionnaire | Baseline | The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. |
| Primary | Erectile Function Assessed by IIEF Questionnaire | Week 2 | The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. |
| Primary | Erectile Function Assessed by IIEF Questionnaire | Week 4 | The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. |
| Primary | Erectile Function Assessed by IIEF Questionnaire | Week 8 | The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. |
| Primary | Erectile Function Assessed by IIEF Questionnaire | Week 12 | The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. |
| Secondary | Health Related Quality of Life as Assessed by the OAB Questionnaire | Baseline | The Overactive Bladder questionnaire (OAB-q) health-related quality of life (HRQL) form will be administered. It is a 13 item tool assessing the health-related quality of life (HRQL) impact of OAB. Scores range from 13 to 78 with higher scores indicating a greater degree of a lower quality of life due to OAB. |
| Secondary | Health Related Quality of Life as Assessed by the OAB Questionnaire | Week 2 | The Overactive Bladder questionnaire (OAB-q) health-related quality of life (HRQL) form will be administered. It is a 13 item tool assessing the health-related quality of life (HRQL) impact of OAB. Scores range from 13 to 78 with higher scores indicating a greater degree of a lower quality of life due to OAB. |
| Secondary | Health Related Quality of Life as Assessed by the OAB Questionnaire | Week 4 | The Overactive Bladder questionnaire (OAB-q) health-related quality of life (HRQL) form will be administered. It is a 13 item tool assessing the health-related quality of life (HRQL) impact of OAB. Scores range from 13 to 78 with higher scores indicating a greater degree of a lower quality of life due to OAB. |
| Secondary | Health Related Quality of Life as Assessed by the OAB Questionnaire | Week 8 | The Overactive Bladder questionnaire (OAB-q) health-related quality of life (HRQL) form will be administered. It is a 13 item tool assessing the health-related quality of life (HRQL) impact of OAB. Scores range from 13 to 78 with higher scores indicating a greater degree of a lower quality of life due to OAB. |
| Secondary | Health Related Quality of Life as Assessed by the OAB Questionnaire | Week 12 | The Overactive Bladder questionnaire (OAB-q) health-related quality of life (HRQL) form will be administered. It is a 13 item tool assessing the health-related quality of life (HRQL) impact of OAB. Scores range from 13 to 78 with higher scores indicating a greater degree of a lower quality of life due to OAB. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Erectile Function Assessed by IIEF Questionnaire | Baseline | score on a scale | MEAN | |
| PRIMARY | Erectile Function Assessed by IIEF Questionnaire | Week 2 | score on a scale | MEAN | |
| PRIMARY | Erectile Function Assessed by IIEF Questionnaire | Week 4 | score on a scale | MEAN | |
| PRIMARY | Erectile Function Assessed by IIEF Questionnaire | Week 8 | score on a scale | MEAN | |
| PRIMARY | Erectile Function Assessed by IIEF Questionnaire | Week 12 | score on a scale | MEAN | |
| SECONDARY | Health Related Quality of Life as Assessed by the OAB Questionnaire | Baseline | score on a scale | MEAN | |
| SECONDARY | Health Related Quality of Life as Assessed by the OAB Questionnaire | Week 2 | score on a scale | MEAN | |
| SECONDARY | Health Related Quality of Life as Assessed by the OAB Questionnaire | Week 4 | score on a scale | MEAN | |
| SECONDARY | Health Related Quality of Life as Assessed by the OAB Questionnaire | Week 8 | score on a scale | MEAN | |
| SECONDARY | Health Related Quality of Life as Assessed by the OAB Questionnaire | Week 12 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Erectile Function Assessed by IIEF Questionnaire | Mirabegron | 12.7 | Standard Deviation 5.4 | score on a scale | |
| Erectile Function Assessed by IIEF Questionnaire | Mirabegron | 13.8 | Standard Deviation 5.1 | score on a scale | |
| Erectile Function Assessed by IIEF Questionnaire | Mirabegron | 15.3 | Standard Deviation 4.2 | score on a scale | |
| Erectile Function Assessed by IIEF Questionnaire | Mirabegron | 17.8 | Standard Deviation 7.9 | score on a scale | |
| Erectile Function Assessed by IIEF Questionnaire | Mirabegron | 15.8 | Standard Deviation 6.9 | score on a scale | |
| Health Related Quality of Life as Assessed by the OAB Questionnaire | Mirabegron | 35.3 | Standard Deviation 13.6 | score on a scale | |
| Health Related Quality of Life as Assessed by the OAB Questionnaire | Mirabegron | 30.7 | Standard Deviation 11.4 | score on a scale | |
| Health Related Quality of Life as Assessed by the OAB Questionnaire | Mirabegron | 30. | Standard Deviation 13.3 | score on a scale | |
| Health Related Quality of Life as Assessed by the OAB Questionnaire | Mirabegron | 26.9 | Standard Deviation 10.6 | score on a scale | |
| Health Related Quality of Life as Assessed by the OAB Questionnaire | Mirabegron | 27.9 | Standard Deviation 14.7 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mirabegron 25 mg to 50 mg Treatment | 20 | |
| Overall Study | COMPLETED | Mirabegron 25 mg to 50 mg Treatment | 13 | |
| Overall Study | NOT COMPLETED | Mirabegron 25 mg to 50 mg Treatment | 7 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | General disorders | Mirabegron 25 mg to 50 mg | 1 | 13 | |
| other | Constipation | Gastrointestinal disorders | Mirabegron 25 mg to 50 mg | 2 | 13 | |
| other | Back or leg pain | Musculoskeletal and connective tissue disorders | Mirabegron 25 mg to 50 mg | 1 | 13 | |
| other | Flu like symptoms | Respiratory, thoracic and mediastinal disorders | Mirabegron 25 mg to 50 mg | 1 | 13 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirabegron 25 mg to 50 mg | 0 | 13 |
| Total, other adverse events | Mirabegron 25 mg to 50 mg | 5 | 13 |
| Total, serious adverse events | Mirabegron 25 mg to 50 mg | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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