NCT03600766

Brief Summary

To study the impact of mirabegron, a B3-adrenoceptor agonist, in the treatment of ED in patients with LUTS secondary to BPH and concomitant ED.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

July 17, 2018

Last Update Submit

September 2, 2019

Conditions

BPHErectile DysfunctionProstate HyperplasiaErectile AbnormalitiesProstatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • assess change erectile function

    measured by International Index of Erectile Function (IIEF).

    1 year

Secondary Outcomes (1)

  • assess change lower urinary tract symptoms (LUTS)

    1 year

Study Arms (2)

Mirabegron

ACTIVE COMPARATOR

oral mirabegron 50 gm plus tamsulosin 0.4 mg once daily for 8 weeks

Drug: Mirabegron

Placebo

ACTIVE COMPARATOR

oral toltordine 4 mg plus tamsulosin 0.4 mg daily for 8 weeks.

Drug: placebo

Interventions

MirabegronDRUG

oral mirabegron 50 gm plus tamsulosin 0.4 mg once daily for 8 weeks.

Mirabegron
placeboDRUG

oral toltordine 4 mg plus tamsulosin 0.4 mg daily for 8 weeks.

Placebo

Eligibility Criteria

Age50 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with concomitant ED and irritative LUTS secondary to BPH
  • Married and sexually motivated.

You may not qualify if:

  • Men with Peyronie's disease.
  • Patients with contraindication to receive mirabegron (High PVR).
  • Psychiatric disorders.
  • Previous pelvic surgery or trauma
  • Men with prostatic adenocarcinoma
  • Patients refusing participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Erectile DysfunctionProstatic HyperplasiaProstatic Neoplasms

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersProstatic DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Ahmed Shokeir, PhD

    urology and nephrology center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

August 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

September 4, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)