Have you or your loved ones been diagnosed with erectile dysfunction?
You may be eligible to participate in a erectile dysfunction clinical trial.
Have you or your loved ones been diagnosed with erectile dysfunction? You may be eligible to participate in a erectile dysfunction clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Erectile Dysfunction Clinical Trial in Baltimore MD
Have you or your loved ones been diagnosed with erectile dysfunction?
You may be eligible to participate in a erectile dysfunction clinical trial.
Have you or your loved ones been diagnosed with erectile dysfunction? You may be eligible to participate in a erectile dysfunction clinical trial.
Completed
Male
18 - 70
Years old
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.
Details for the study
Brief Title
Mirabegron For Erectile Dysfunction
Official Title
Mirabegron For Erectile Dysfunction
Brief Summary
The only class of oral erectile dysfunction (ED) medication on the market are the <br /> phosphodiesterase Type 5 inhibitors (PDE5i). This pilot study is being done to evaluate the <br /> effect of Mirabegron, an oral beta-3 adrenergic agonist, on men with both Overactive Bladder <br /> (OAB) symptoms and mild to moderate ED.
Detailed Description
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.
Treatments and/or Procedures
Mirabegron
FDA-approved, beta 3 agonist for over active bladder
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
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.
Primary
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.
Primary
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.
Primary
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.
Primary
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.
Secondary
Health Related Quality of Life as Assessed by the OAB Questionnaire
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.
Secondary
Health Related Quality of Life as Assessed by the OAB Questionnaire
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.
Secondary
Health Related Quality of Life as Assessed by the OAB Questionnaire
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.
Secondary
Health Related Quality of Life as Assessed by the OAB Questionnaire
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.
Secondary
Health Related Quality of Life as Assessed by the OAB Questionnaire
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.
Study 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