BPHNCT00256399
Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)
A study testing Alfuzosin 10 mg in people with BPH and Erectile Dysfunction, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- BPH, Erectile Dysfunction
- What is being tested?
- Alfuzosin 10 mg
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to 8 May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Prostate cancer
- Prostatitis
- Penile disease
- Cardiac co-morbidity
- Pre-existing co-morbid conditions
- History of sensitivity to the drug or similar drugs
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: A Prospective, Open Label, Study to Assess the Efficacy of Alfuzosin 10 mg Tablet Once a Day in Male Subjects Suffering From Benign Prostate Hypertrophy Associated Lower Urinary Tract Symptoms and Erectile Dysfunction
Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.
Read the 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.
- Conditions
- BPH, Erectile Dysfunction
- Being tested
- Alfuzosin 10 mg
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzosin 10 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the medication on erection maintenance
Secondary outcomes (1)
Assess effect of Uroxatral on BPH and sexual function using questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startNov 2005
- Primary completion8 May 2007
- Study completion8 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Allen D Seftel, MD, Principal investigator, University Urologists of Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256399
- Sponsor's protocol ID
- L-9835
- Status last verified
- Nov 2005
- First submitted
- 18 Nov 2005
- Last updated
- 15 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Study to Assess the Efficacy of Alfuzosin 10 mg Tablet Once a Day in Male Subjects Suffering From Benign Prostate Hypertrophy Associated Lower Urinary Tract Symptoms and Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT00256399
- Acronym / sponsor ID
- L-9835
- Conditions
- BPH, Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Nov 2005
- Primary completion
- 8 May 2007 (actual)
- Study completion
- 8 May 2007 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- Prostate cancer
- Prostatitis
- Penile disease
- Cardiac co-morbidity
- Pre-existing co-morbid conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alfuzosin 10 mg | Drug | – |
Primary outcome
Evaluate the medication on erection maintenance
1 secondary outcome
Assess effect of Uroxatral on BPH and sexual function using questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen D Seftel, MD principal investigator
University Urologists of Cleveland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alfuzosin 10 mg in people with BPH and Erectile Dysfunction, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the medication on erection maintenance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.