Mirabegron For Erectile Dysfunction

Completed · Phase 1/Phase 2

Conditions studied: Erectile Dysfunction, Overactive Bladder, Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT02916693

Run by

Johns Hopkins University

People needed

20

Starts

2017-08-01

Expected to finish

2020-01-01

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• Johns Hopkins Medical Institutions — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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