Uroxatral in Men With Benign Prostate Hypertrophy (BPH) a... | NCT00256399

Studies
Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)

NCT00256399

Sponsor

University Hospitals Cleveland Medical Center

Status

Completed

Last Update Posted

Aug 15, 2022Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

BPH
Erectile Dysfunction

Interventions

Alfuzosin 10 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

May 8, 2007Actual

Completion Date

May 8, 2007Actual

First Submitted Date

Nov 18, 2005

First Submission Date that Met QC Criteria

Nov 18, 2005

First Posted Date

Nov 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2022

Last Update Posted Date

Aug 15, 2022Actual

Name	Class
Sanofi	INDUSTRY

Description Module

Brief Summary

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

Detailed Description

The study will consist of a 30 day screening/washout phase at the end of which qualified subjects will be assigned to alfuzosin 10 mg tablets once a day. Subjects will be treated for 90 days. The total duration of the study will be 120 days.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Name	Type	Description	Arm Group Labels	Other Names
Alfuzosin 10 mg	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the medication on erection maintenance

Secondary Outcomes

Measure	Description	Time Frame
Assess effect of Uroxatral on BPH and sexual function using questionnaires

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allen D Seftel, MD	University Urologists of Cleveland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Cleveland		Cleveland	Ohio	44106	United States

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C047638	alfuzosin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided