ImpotencePhase 2NCT00141349
Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction
A Phase 2 study testing UK-369,003 in people with Impotence, run by Pfizer at 39 sites in United States.
Trial summary
To determine the onset of action, safety and toleration of different formulations and doses of UK-369,003 in patients with erectile dysfunction. Patients should have been previously treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Impotence
- What is being tested?
- UK-369,003
- How many people
- 300 participants
- Where
- 39 sitesUnited States
- Study dates
- Feb 2005to Aug 2005
- Phase
- Phase 2
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Erectile dysfunction as defined by DSM-IV. Patients should have been PDE5 inhibitor respondents
Who cannot join
- Alpha blockers and Nitrates of any preparation
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Pfizer Investigational Site
Albany, New York, 12206
Pfizer Investigational Site
Aventura, Florida, 33180
Pfizer Investigational Site
Beachwood, Ohio, 44122-5402
Pfizer Investigational Site
Beverly Hills, California, 90212
Pfizer Investigational Site
Birmingham, Alabama, 35205
Pfizer Investigational Site
Birmingham, Alabama, 35209-5603
Pfizer Investigational Site
Birmingham, Alabama, 35215
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
Cincinnati, Ohio, 45212
Pfizer Investigational Site
Cleveland, Ohio, 44122
Pfizer Investigational Site
Endwell, New York, 13760
Pfizer Investigational Site
Evansville, Indiana, 47714
Pfizer Investigational Site
Fort Wayne, Indiana, 46825
Pfizer Investigational Site
Jeffersonville, Indiana, 47130
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Mesa, Arizona, 85201
Pfizer Investigational Site
Mesa, Arizona, 85206
Pfizer Investigational Site
Mesa, Arizona, 85213
Pfizer Investigational Site
Metairie, Louisiana, 70002
Pfizer Investigational Site
Metairie, Louisiana, 70006
Pfizer Investigational Site
Milford, Massachusetts, 01757
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
New Brunswick, New Jersey, 08903
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
Pembroke Pines, Florida, 33028
Pfizer Investigational Site
Raleigh, North Carolina, 27609-7216
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
San Bernardino, California, 92404
Pfizer Investigational Site
St. Petersburg, Florida, 33709
Pfizer Investigational Site
Sugar Land, Texas, 77478
Pfizer Investigational Site
Tempe, Arizona, 85282
Pfizer Investigational Site
Torrance, California, 90505
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
West Jordan, Utah, 84088
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Assess the Time to Onset, Safety, and Toleration of Differing Doses and Combinations of Immediate Release and Modified Release Formulations of UK369,003 in Adult Male Subject With Erectile Dysfunction
To determine the onset of action, safety and toleration of different formulations and doses of UK-369,003 in patients with erectile dysfunction. Patients should have been previously treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is 4 weeks.
- Conditions
- Impotence
- Being tested
- UK-369,003
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UK-369,003Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The time needed to obtain an erection hard enough to attempt sexual intercourse.
Secondary outcomes (1)
Proportion of responders based on successful erections Based on erections hard enough for sexual intercourse 15, 45 and 60 minutes post dose Proportion of good responders based on successful erections International Index of Erectile Function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpotenceStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141349
- Sponsor's protocol ID
- A3711029
- Status last verified
- Jan 2006
- First submitted
- 30 Aug 2005
- Last updated
- 25 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Assess the Time to Onset, Safety, and Toleration of Differing Doses and Combinations of Immediate Release and Modified Release Formulations of UK369,003 in Adult Male Subject With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT00141349
- Acronym / sponsor ID
- A3711029
- Conditions
- Impotence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- Aug 2005
- First posted
- 1 Sep 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.
To determine the onset of action, safety and toleration of different formulations and doses of UK-369,003 in patients with erectile dysfunction. Patients should have been previously treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Erectile dysfunction as defined by DSM-IV. Patients should have been PDE5 inhibitor respondents
Key exclusion criteria (1 listed)
- Alpha blockers and Nitrates of any preparation
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 |
|---|---|---|
| UK-369,003 | Drug | – |
Primary outcome
The time needed to obtain an erection hard enough to attempt sexual intercourse.
1 secondary outcome
Proportion of responders based on successful erections Based on erections hard enough for sexual intercourse 15, 45 and 60 minutes post dose Proportion of good responders based on successful erections International Index of Erectile Function
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 25 Jul 2006.
Related trials for Impotence
Recruiting
Aerobic Exercise Addition to Cognitive Behavioural Treatment in Impotence Metabolic-syndrome Drinkers
Heavy Drinking, Metabolic Syndrome
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.
Pfizer CT.gov Call Center study director
Pfizer
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UK-369,003 in people with Impotence, run by Pfizer at 39 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 1 inclusion and 1 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 25 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The time needed to obtain an erection hard enough to attempt sexual intercourse.. 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 25 Jul 2006; AzTrials last refreshed its copy on 8 Nov 2026.