EjaculationPhase 2/3NCT00219635
Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation
A Phase 2/3 study testing UK-390,957 in people with Ejaculation, run by Pfizer at 22 sites in 4 countries.
Trial summary
Assessment of efficacy and safety UK-390,957 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Ejaculation
- What is being tested?
- UK-390,957
- How many people
- 138 participants
- Where
- 22 sitesin 4 countries
- Study dates
- Jan 2005to Jul 2005
- Phase
- Phase 2/3
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premature ejaculation as defined by DSM-IV
Who cannot join
- History of erectile dysfunction
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States14 sites
Pfizer Investigational Site
Beachwood, Ohio
Pfizer Investigational Site
Birmingham, Alabama
Pfizer Investigational Site
Dallas, Texas
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Kansas City, Missouri
Pfizer Investigational Site
Knoxville, Tennessee
Pfizer Investigational Site
Metairie, Louisiana
Pfizer Investigational Site
Milwaukee, Wisconsin
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
San Bernardino, California
Pfizer Investigational Site
Washington, Missouri
Pfizer Investigational Site
Watertown, Massachusetts
Pfizer Investigational Site
Williamsville, New York
Canada4 sites
Pfizer Investigational Site
Barrie, Ontario
Pfizer Investigational Site
London, Ontario
Pfizer Investigational Site
Toronto, Ontario
Pfizer Investigational Site
Victoria, British Columbia
Australia2 sites
Pfizer Investigational Site
Malvern, Victoria
Pfizer Investigational Site
St Leonards, New South Wales
United Kingdom2 sites
Pfizer Investigational Site
Devon
Pfizer Investigational Site
Nr Lichfield, Staffordshire
About this study
Official title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study To Assess The Efficacy and Safety Of Oral UK-390,957 In Men With Premature Ejaculation
Assessment of efficacy and safety UK-390,957
- Conditions
- Ejaculation
- Being tested
- UK-390,957
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UK-390,957Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of efficacy and safety
Secondary outcomes (1)
Assessment of quality of sexual life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EjaculationStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 138 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219635
- Sponsor's protocol ID
- A3871029
- Status last verified
- Nov 2012
- First submitted
- 9 Sep 2005
- Last updated
- 7 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study To Assess The Efficacy and Safety Of Oral UK-390,957 In Men With Premature Ejaculation
- ClinicalTrials.gov ID
- NCT00219635
- Acronym / sponsor ID
- A3871029
- Conditions
- Ejaculation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 22 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.
Assessment of efficacy and safety UK-390,957
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Premature ejaculation as defined by DSM-IV
Key exclusion criteria (1 listed)
- History of erectile dysfunction
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-390,957 | Drug | – |
Primary outcome
Assessment of efficacy and safety
1 secondary outcome
Assessment of quality of sexual life
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 7 Nov 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Ejaculation
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Ejaculatory and Orgasmic Dysfunction Registry
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Enlarged Prostate (BPH), Enlarged Prostate With Lower Urinary Tract Symptoms
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Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
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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.
Pfizer CT.gov Call Center study director
Pfizer
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing UK-390,957 in people with Ejaculation, run by Pfizer at 22 sites in 4 countries.
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 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, Australia, United Kingdom. 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 combined 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.
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?
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?
Assessment of efficacy and safety. 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 7 Nov 2012.