NCT00256399

Brief Summary

Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2007

Completed
Last Updated

August 15, 2022

Status Verified

November 1, 2005

Enrollment Period

1.5 years

First QC Date

November 18, 2005

Last Update Submit

August 10, 2022

Conditions

BPHErectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Evaluate the medication on erection maintenance

Secondary Outcomes (1)

  • Assess effect of Uroxatral on BPH and sexual function using questionnaires

Interventions

Alfuzosin 10 mgDRUG

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males 45-75 years of age
  • Confirmed diagnosis of BPH/lower urinary tract symptoms (LUTS) and ED
  • Men with steady partner and who agree to attempt sex once a week.

You may not qualify if:

  • Prostate cancer
  • Prostatitis
  • Penile disease
  • Cardiac co-morbidity
  • Pre-existing co-morbid conditions
  • History of sensitivity to the drug or similar drugs
  • Enrollment in another clinical trial
  • Impaired hepatic function
  • Impaired renal function
  • Mental conditions rendering subject unable to understand the study
  • Subjects not likely to comply with protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Allen D Seftel, MD

    University Urologists of Cleveland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 21, 2005

Study Start

November 1, 2005

Primary Completion

May 8, 2007

Study Completion

May 8, 2007

Last Updated

August 15, 2022

Record last verified: 2005-11

Locations

US(1)