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Trial Outcomes & Findings for Mirabegron For Erectile Dysfunction (NCT NCT02916693)

NCT ID: NCT02916693

Last Updated: 2021-01-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Week 8

Results posted on

2021-01-05

Participant Flow

Participant milestones

Participant milestones
Measure
Mirabegron 25 mg to 50 mg Treatment
Single-center, non-randomized, single-arm study
Overall Study
STARTED
20
Overall Study
COMPLETED
13
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Mirabegron 25 mg to 50 mg Treatment
Single-center, non-randomized, single-arm study
Overall Study
Lost to Follow-up
7

Baseline Characteristics

Mirabegron For Erectile Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mirabegron 25 mg to 50 mg Treatment
n=20 Participants
Single-center, non-randomized, single-arm study Participants received Mirabegron 25 mg for 2 weeks and switched to the 50 mg for 10 weeks
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=5 Participants
Age, Categorical
>=65 years
8 Participants
n=5 Participants
Age, Continuous
60.2 years
STANDARD_DEVIATION 6.82 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
20 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Co-morbidities
Diabetes Mellitus
2 Participants
n=5 Participants
Co-morbidities
Hypertension
8 Participants
n=5 Participants
Co-morbidities
Hyperlipidemia
8 Participants
n=5 Participants
Co-morbidities
Cardiovascular disease
2 Participants
n=5 Participants
Smoking History
Never Smoker
10 Participants
n=5 Participants
Smoking History
Current Smoker
3 Participants
n=5 Participants
Smoking History
Ex-smoker
7 Participants
n=5 Participants
Erectile Dysfunction (ED) Severity
Mild
3 Participants
n=5 Participants
Erectile Dysfunction (ED) Severity
Mild to moderate
6 Participants
n=5 Participants
Erectile Dysfunction (ED) Severity
Moderate
11 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mirabegron
n=20 Participants
Baseline IIEF scores of participants
Erectile Function Assessed by IIEF Questionnaire
12.7 score on a scale
Standard Deviation 5.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mirabegron
n=13 Participants
Baseline IIEF scores of participants
Erectile Function Assessed by IIEF Questionnaire
13.8 score on a scale
Standard Deviation 5.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mirabegron
n=13 Participants
Baseline IIEF scores of participants
Erectile Function Assessed by IIEF Questionnaire
15.3 score on a scale
Standard Deviation 4.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mirabegron
n=13 Participants
Baseline IIEF scores of participants
Erectile Function Assessed by IIEF Questionnaire
17.8 score on a scale
Standard Deviation 7.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mirabegron
n=13 Participants
Baseline IIEF scores of participants
Erectile Function Assessed by IIEF Questionnaire
15.8 score on a scale
Standard Deviation 6.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mirabegron
n=20 Participants
Baseline IIEF scores of participants
Health Related Quality of Life as Assessed by the OAB Questionnaire
35.3 score on a scale
Standard Deviation 13.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mirabegron
n=13 Participants
Baseline IIEF scores of participants
Health Related Quality of Life as Assessed by the OAB Questionnaire
30.7 score on a scale
Standard Deviation 11.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mirabegron
n=13 Participants
Baseline IIEF scores of participants
Health Related Quality of Life as Assessed by the OAB Questionnaire
30. score on a scale
Standard Deviation 13.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mirabegron
n=13 Participants
Baseline IIEF scores of participants
Health Related Quality of Life as Assessed by the OAB Questionnaire
26.9 score on a scale
Standard Deviation 10.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mirabegron
n=13 Participants
Baseline IIEF scores of participants
Health Related Quality of Life as Assessed by the OAB Questionnaire
27.9 score on a scale
Standard Deviation 14.7

Adverse Events

Mirabegron 25 mg to 50 mg

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Mirabegron 25 mg to 50 mg
n=13 participants at risk
Single-center, non-randomized, single-arm study Participants received Mirabegron 25 mg for 2 weeks and switched to the 50 mg for 10 weeks.
General disorders
Headache
7.7%
1/13 • 3 months
Gastrointestinal disorders
Constipation
15.4%
2/13 • 3 months
Musculoskeletal and connective tissue disorders
Back or leg pain
7.7%
1/13 • 3 months
Respiratory, thoracic and mediastinal disorders
Flu like symptoms
7.7%
1/13 • 3 months

Additional Information

Dr. Arthur L. Burnett

Johns Hopkins University

Phone: 410-614-3986

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place