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Trial record 22 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Erectile Dysfunction"

Mirabegron For Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT02916693
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Overactive Bladder Urinary Incontinence Drug: Mirabegron Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mirabegron For Erectile Dysfunction
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mirabegron
Participants take 25- 50mg oral Mirabegron tablets daily for 12 weeks,
Drug: Mirabegron
FDA-approved, beta 3 agonist for over active bladder
Other Name: Myrbetriq



Primary Outcome Measures :
  1. Change in erectile function (EF) [ Time Frame: baseline to Week 2 post intervention ]
    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

  2. change in EF [ Time Frame: baseline to Week 4 post intervention ]
    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

  3. change in EF [ Time Frame: Baseline to Week 8 post intervention ]
    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

  4. change in EF [ Time Frame: Baseline to week 12 post intervention ]
    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 Outcome Measures :
  1. change in OAB symptoms' impact on health related quality of life [ Time Frame: baseline to Week 2 post intervention ]
    The Overactive Bladder questionnaire (OAB-q) will be administered. It is a 19 item tool assessing degree of OAB symptom bother and quality of life. Higher scores indicate a greater degree of both and a lower quality of life

  2. change in OAB symptoms' impact on health related quality of life [ Time Frame: baseline to Week 4 post intervention ]
    The Overactive Bladder questionnaire (OAB-q) will be administered. It is a 19 item tool assessing degree of OAB symptom bother and quality of life. Higher scores indicate a greater degree of both and a lower quality of life

  3. change in OAB symptoms' impact on health related quality of life [ Time Frame: baseline to Week 8 post intervention ]
    The Overactive Bladder questionnaire (OAB-q) will be administered. It is a 19 item tool assessing degree of OAB symptom bother and quality of life. Higher scores indicate a greater degree of both and a lower quality of life

  4. change in OAB symptoms' impact on health related quality of life [ Time Frame: baseline to Week 12 post intervention ]
    The Overactive Bladder questionnaire (OAB-q) will be administered. It is a 19 item tool assessing degree of OAB symptom bother and quality of life. Higher scores indicate a greater degree of both and a lower quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916693


Contacts
Contact: Angela Koomson 410-502-6407 akoomso1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21287
Contact: Angela Koomson    410-502-6407    akoomso1@jhmi.edu   
Principal Investigator: Arthur L Burnett, MD, MBA         
Sponsors and Collaborators
Johns Hopkins University
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Arthur L Burnett, M.D., M.B.A. Johns Hopkins, School of Medicine

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02916693     History of Changes
Other Study ID Numbers: IRB00097439
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Mirabegron
Overactive Bladder
Erectile Dysfunction
Beta 3 agonist

Additional relevant MeSH terms:
Erectile Dysfunction
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents