NCT02916693

Brief Summary

The only class of oral erectile dysfunction (ED) medication on the market are the phosphodiesterase Type 5 inhibitors (PDE5i). This pilot study is being done to evaluate the effect of Mirabegron, an oral beta-3 adrenergic agonist, on men with both Overactive Bladder (OAB) symptoms and mild to moderate ED.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2.4 years

First QC Date

September 22, 2016

Results QC Date

December 8, 2020

Last Update Submit

December 8, 2020

Conditions

Erectile DysfunctionOveractive BladderUrinary Incontinence

Keywords

MirabegronOveractive BladderErectile DysfunctionBeta 3 agonist

Outcome Measures

Primary Outcomes (5)

  • Erectile Function Assessed by IIEF Questionnaire

    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.

    Baseline

  • Erectile Function Assessed by IIEF Questionnaire

    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.

    Week 2

  • Erectile Function Assessed by IIEF Questionnaire

    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.

    Week 4

  • Erectile Function Assessed by IIEF Questionnaire

    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.

    Week 8

  • Erectile Function Assessed by IIEF Questionnaire

    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.

    Week 12

Secondary Outcomes (5)

  • Health Related Quality of Life as Assessed by the OAB Questionnaire

    Baseline

  • Health Related Quality of Life as Assessed by the OAB Questionnaire

    Week 2

  • Health Related Quality of Life as Assessed by the OAB Questionnaire

    Week 4

  • Health Related Quality of Life as Assessed by the OAB Questionnaire

    Week 8

  • Health Related Quality of Life as Assessed by the OAB Questionnaire

    Week 12

Study Arms (1)

Mirabegron

EXPERIMENTAL

Participants take 25- 50mg oral Mirabegron tablets daily for 12 weeks,

Drug: Mirabegron

Interventions

MirabegronDRUG

FDA-approved, beta 3 agonist for over active bladder

Also known as: Myrbetriq
Mirabegron

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of mild ED \[Erectile Function domain of the International Index of Erectile Function (IIEF EF) score 22-25\], mild to moderate ED (IIEF EF domain score 17-21) or moderate ED (IIEF EF domain score 11-16)
  • presence of OAB symptoms for at least 3 months
  • at least 3 micturitions per day
  • at least 3 episodes of urgency in a 3 day period

You may not qualify if:

  • history of pelvic surgery
  • concurrent ED therapy
  • history of penile surgery
  • history of priapism (unwanted, prolonged painful erection)
  • history of neurologic disease
  • uncontrolled hypertension: systolic blood pressure (BP) \> 140 mmHg or diastolic BP \> 90 mmHg
  • Stage 4 or 5 chronic kidney disease, Creatinine clearance rate \< 30ml/min
  • moderate or severe hepatic impairment
  • concomitant use of CYP2D6-metabolized drugs or digoxin
  • post void residual greater than 150 ml
  • evidence of urinary tract infection on urinalysis and/or urine culture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Erectile DysfunctionUrinary Bladder, OveractiveUrinary Incontinence

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

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.

Results Point of Contact

Title
Dr. Arthur L. Burnett
Organization
Johns Hopkins University
aburnet1@jhmi.edu
410-614-3986

Study Officials

  • Arthur L Burnett, M.D., M.B.A.

    Johns Hopkins, School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 27, 2016

Study Start

August 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 5, 2021

Results First Posted

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)