Mirabegron For Erectile Dysfunction

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Mirabegron

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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