Erectile DysfunctionPhase 3NCT00893113
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
A Phase 3 study testing Alfuzosin in people with Erectile Dysfunction and Lower Urinary Tract Symptoms, run by Chesapeake Urology Research Associates at 4 sites in United States.
Trial summary
The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF). Read more about this study
- Who is it for?
- Ages 30 to 69 years, men only
- Conditions the study is for
- Erectile Dysfunction, Lower Urinary Tract Symptoms
- What is being tested?
- Alfuzosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2009to Oct 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, 30-69 years of age
- Has mild to moderate Erectile Dysfunction with a score < 25 on EF domain in IIEF
- AUA score of less than or equal to 14
- Negative urinalysis with no evidence of a Urinary Tract Infection
Who cannot join
- Blood pressure < 90/50 or > 170/110
- Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)
- Diabetes Mellitus
- History of PSA > 10
- History of confirmed or suspected prostate cancer
- History of Moderate/Severe Hepatic Insufficiency defined as > 2X ULN
- On Alpha Blocker or PDE 5 inhibitor within 2 weeks of randomization
- Receive treatment with other investigational agents within 30 days prior to enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Chesapeake Urology Research Associates
Baltimore, Maryland, 21204
Chesapeake Urology Research Associates
Baltimore, Maryland, 21237
Chesapeake Urology Research Associates
Glen Burnie, Maryland, 21061
Chesapeake Urology Research Associates
Towson, Maryland, 21204
About this study
Official title: A Phase 3, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Alfuzosin in Treating Men With ED and Mild LUTS.
The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).
Read the detailed description
This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.
- Conditions
- Erectile Dysfunction, Lower Urinary Tract Symptoms
- Being tested
- Placebo, Alfuzosin
- Medical subject headings
- Erectile Dysfunction, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Alfuzosin-matched One tablet once daily
AlfuzosinDrug
10 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo, Then Alfuzosin | Placebo comparator | Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks. Receives: Drug: Placebo; Drug: Alfuzosin |
| Alfuzosin, Then Placebo | Experimental | Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks. Receives: Drug: Placebo; Drug: Alfuzosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Erectile Function Domain of the International Index of Erectile Function
The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.
Measured: Baseline and 12 Weeks
Secondary outcomes (2)
Changes in American Urological Association (AUA) Symptom Index
The American Urological Association (AUA) Symptom Index is used to evaluate the severity of the patient's enlarged prostate symptoms. The AUA Symptom Index is completed by the patient. Questions are based on patient experiences in the past month and are answered on a scale of 0-5 (0 = not at all, 1 = less than one time in 5, 2 = less than half the time, 3 = about half the time, 4 = more than half the time, 5 = almost always). The scores are totaled and ranked as follows: mild (1-7), moderate (8-19), and severe (20-35).
Measured: Baseline and 12 Weeks
Change in Total International Index of Erectile Function (IIEF) Score
The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chesapeake Urology Research Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Ronald F Tutrone, MD, Principal investigator, Chesapeake Urology Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893113
- Sponsor's protocol ID
- CURA-RT-002
- Status last verified
- Feb 2018
- First submitted
- 8 Apr 2009
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Alfuzosin in Treating Men With ED and Mild LUTS.
- ClinicalTrials.gov ID
- NCT00893113
- Acronym / sponsor ID
- CURA-RT-002
- Conditions
- Erectile Dysfunction, Lower Urinary Tract Symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Chesapeake Urology Research AssociatesUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jun 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 May 2009 (estimated)
- Results
- Posted 1 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).
Detailed description
This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo, Then Alfuzosin | Placebo comparator | Drug: Placebo, Drug: AlfuzosinParticipants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks. |
| Alfuzosin, Then Placebo | Experimental | Drug: Placebo, Drug: AlfuzosinParticipants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male, 30-69 years of age
- Has mild to moderate Erectile Dysfunction with a score < 25 on EF domain in IIEF
- AUA score of less than or equal to 14
- Negative urinalysis with no evidence of a Urinary Tract Infection
Key exclusion criteria (8 listed)
- Blood pressure < 90/50 or > 170/110
- Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)
- Diabetes Mellitus
- History of PSA > 10
- History of confirmed or suspected prostate cancer
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 |
|---|---|---|
| PlaceboAlfuzosin-matched One tablet once daily | Drug | Alfuzosin, Then Placebo, Placebo, Then Alfuzosin |
| Alfuzosin10 mg once daily | Drug | Alfuzosin, Then Placebo, Placebo, Then Alfuzosin |
Primary outcome
Change From Baseline Erectile Function Domain of the International Index of Erectile Function
Time frame: Baseline and 12 Weeks
The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.
2 secondary outcomes
Changes in American Urological Association (AUA) Symptom Index
Time frame: Baseline and 12 Weeks
Change in Total International Index of Erectile Function (IIEF) Score
Time frame: Baseline and 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ronald F Tutrone, MD principal investigator
Chesapeake Urology Research Associates
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alfuzosin in people with Erectile Dysfunction and Lower Urinary Tract Symptoms, run by Chesapeake Urology Research Associates at 4 sites 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 4 inclusion and 8 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline Erectile Function Domain of the International Index of Erectile Function (time frame: Baseline and 12 Weeks). 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 9 Mar 2018.