Mirabegron For Erectile Dysfunction
| Status: | Recruiting |
|---|---|
| Conditions: | Erectile Dysfunction, Overactive Bladder, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/20/2019 |
| Start Date: | August 1, 2017 |
| End Date: | July 31, 2019 |
| Contact: | Angela Koomson |
| Email: | akoomso1@jhmi.edu |
| Phone: | 410-502-6407 |
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.
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.
ED affects up to 30 million men in the United States. The only class of oral medication
approved for ED is PDE5i. These include sildenafil, tadalafil, vardenafil and avanafil. Other
pharmacologic options in the treatment of ED are delivered as an intraurethral suppository
(alprostadil) or intracavernosal injection (alprostadil, papaverine, phentolamine, atropine).
These are more invasive routes of administration. Men who fail to obtain benefit from a PDE5i
or those who have a contraindication to this class of medication may ultimately avoid further
pharmacologic treatment options. An alternative class of oral medication to treat ED may
prove to be of benefit to a large population of underserved men.
There is in vitro evidence that beta-3 adrenergic receptors exist in human corpus cavernosum
tissue. Activation of these receptors results in vasorelaxation, suggesting a potential
pro-erectogenic effect is possible in vivo. Additionally, nebivolol, a beta-blocker, has
pro-erectogenic effects noted in several studies. There is evidence that nebivolol exerts
beta-3 adrenergic agonism, which may explain the mechanism by which these effects occur.
Mirabegron is the only available beta-3 adrenergic agonist in the United States. Its
favorable safety profile and the potential for therapeutic efficacy in ED make it suitable
for further investigation.
It is hypothesized that beta-3 adrenergic activation offers a pharmacologic target for the
treatment of ED. Men with mild, mild to moderate, or moderate ED and symptoms of OAB can be
recruited with pre- and post- Mirabegron administration assessment of their ED to determine
the validity of this hypothesis. Men with severe ED will be excluded as historical data shows
they are less likely to benefit from oral pharmacologic therapy alone. Mirabegron is approved
by the U.S. Food and Drug Administration (FDA) for the treatment of adults with OAB.
approved for ED is PDE5i. These include sildenafil, tadalafil, vardenafil and avanafil. Other
pharmacologic options in the treatment of ED are delivered as an intraurethral suppository
(alprostadil) or intracavernosal injection (alprostadil, papaverine, phentolamine, atropine).
These are more invasive routes of administration. Men who fail to obtain benefit from a PDE5i
or those who have a contraindication to this class of medication may ultimately avoid further
pharmacologic treatment options. An alternative class of oral medication to treat ED may
prove to be of benefit to a large population of underserved men.
There is in vitro evidence that beta-3 adrenergic receptors exist in human corpus cavernosum
tissue. Activation of these receptors results in vasorelaxation, suggesting a potential
pro-erectogenic effect is possible in vivo. Additionally, nebivolol, a beta-blocker, has
pro-erectogenic effects noted in several studies. There is evidence that nebivolol exerts
beta-3 adrenergic agonism, which may explain the mechanism by which these effects occur.
Mirabegron is the only available beta-3 adrenergic agonist in the United States. Its
favorable safety profile and the potential for therapeutic efficacy in ED make it suitable
for further investigation.
It is hypothesized that beta-3 adrenergic activation offers a pharmacologic target for the
treatment of ED. Men with mild, mild to moderate, or moderate ED and symptoms of OAB can be
recruited with pre- and post- Mirabegron administration assessment of their ED to determine
the validity of this hypothesis. Men with severe ED will be excluded as historical data shows
they are less likely to benefit from oral pharmacologic therapy alone. Mirabegron is approved
by the U.S. Food and Drug Administration (FDA) for the treatment of adults with OAB.
Inclusion Criteria:
- presence of mild ED (IIEF EF domain 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
We found this trial at
1
site
Baltimore, Maryland 21287
Principal Investigator: Arthur L Burnett, MD, MBA
Phone: 410-502-6407
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