EjaculationPhase 2/3NCT00219609
Assessment Of Safety Of UK-390,957
A Phase 2/3 study testing UK-390,957 in people with Ejaculation, run by Pfizer at 82 sites in 14 countries.
Trial summary
To determine whether UK-390,957 is a safe treatment for premature ejaculation. 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
- 1,058 participants
- Where
- 82 sitesin 14 countries
- Study dates
- Jan 2005to Mar 2006
- 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
- Subjects will have completed one of the phase 2 trials (A3871022/ A3871027/ A3871029) and will have met the diagnostic criteria for premature ejaculation as defined by DSM-IV
Who cannot join
- No drug related serious adverse events
Trial locations and contacts
82 sites in 14 countries.
82 sites in 14 countries
United States46 sites
Pfizer Investigational Site
Albany, New York
Pfizer Investigational Site
Anaheim, California
Pfizer Investigational Site
Atherton, California
Pfizer Investigational Site
Aurora, Colorado
Pfizer Investigational Site
Aventura, Florida
Pfizer Investigational Site
Beachwood, Ohio
Pfizer Investigational Site
Beverly Hills, California
Pfizer Investigational Site
Charlotte, North Carolina
Pfizer Investigational Site
Dallas, Texas
Pfizer Investigational Site
Durham, North Carolina
Pfizer Investigational Site
Edison, New Jersey
Pfizer Investigational Site
Endwell, New York
Pfizer Investigational Site
Evansville, Indiana
Pfizer Investigational Site
Fort Wayne, Indiana
Pfizer Investigational Site
Germantown, Tennessee
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Indianapolis, Indiana
Pfizer Investigational Site
Kansas City, Missouri
Pfizer Investigational Site
Knoxville, Tennessee
Pfizer Investigational Site
Laguna Woods, California
Pfizer Investigational Site
Lexington, Kentucky
Pfizer Investigational Site
Madisonville, Kentucky
Pfizer Investigational Site
Memphis, Tennessee
Pfizer Investigational Site
Metairie, Louisiana
Pfizer Investigational Site
Milan, Tennessee
Pfizer Investigational Site
Milwaukee, Wisconsin
Pfizer Investigational Site
Milwuakee, Wisconsin
Pfizer Investigational Site
Minneapolis, Minnesota
Pfizer Investigational Site
New Brunswick, New Jersey
Pfizer Investigational Site
New Port Richey, Florida
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
Newport Beach, California
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
Redwood City, California
Pfizer Investigational Site
Saint Clair Shores, Michigan
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
San Diego, California
Pfizer Investigational Site
Southhaven, Mississippi
Pfizer Investigational Site
Tarzana, California
Pfizer Investigational Site
Tucson, Arizona
Pfizer Investigational Site
Vorhees, New Jersey
Pfizer Investigational Site
Walnut Creek, California
Pfizer Investigational Site
Waterbury, Connecticut
Pfizer Investigational Site
Watertown, Massachusetts
Pfizer Investigational Site
West Seneca, New York
Pfizer Investigational Site
Williamsville, New York
Canada6 sites
Pfizer Investigational Site
Barrie, Ontario
Pfizer Investigational Site
London, Ontario
Pfizer Investigational Site
Montréal, Quebec
Pfizer Investigational Site
Montreal, Quebec
Pfizer Investigational Site
Oakville, Ontario
Pfizer Investigational Site
Toronto, Ontario
Australia5 sites
Pfizer Investigational Site
Adelaide, South Australia
Pfizer Investigational Site
Malvern, Victoria
Pfizer Investigational Site
Nedlands, Western Australia
Pfizer Investigational Site
Spring Hill, Queensland
Pfizer Investigational Site
St Leonards, New South Wales
Israel4 sites
Pfizer Investigational Site
Beersheba
Pfizer Investigational Site
Haifa
Pfizer Investigational Site
Tel Aviv
Pfizer Investigational Site
Tel HaShomer
Germany3 sites
Pfizer Investigational Site
Hamburg
Pfizer Investigational Site
Hanover
Pfizer Investigational Site
München
Turkey (Türkiye)3 sites
Pfizer Investigational Site
Balcali, Adana
Pfizer Investigational Site
Balçova, İzmir
Pfizer Investigational Site
Samanpazarı, Ankara
Austria2 sites
Pfizer Investigational Site
Mistelbach
Pfizer Investigational Site
Salzburg
Czechia2 sites
Pfizer Investigational Site
Brno
Pfizer Investigational Site
Prague
Norway2 sites
Pfizer Investigational Site
Moelv
Pfizer Investigational Site
Oslo
Poland2 sites
Pfizer Investigational Site
Mysłowice
Pfizer Investigational Site
Warsaw
Sweden2 sites
Pfizer Investigational Site
Skövde
Pfizer Investigational Site
Stockholm
United Kingdom2 sites
Pfizer Investigational Site
Devon
Pfizer Investigational Site
Nr Lichfield, Staffordshire
About this study
Official title: A Phase 2 Multi-Center, Open Label Long-Term Extension Trial To Assess The Safety Of Oral Uk-390,957 Administered As Required In Adult Men With Premature Ejaculation
To determine whether UK-390,957 is a safe treatment for premature ejaculation.
- 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 safety
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 completionMar 2006
- Study completionMar 2006
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,058 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
- NCT00219609
- Sponsor's protocol ID
- A3871028
- 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, Open Label Long-Term Extension Trial To Assess The Safety Of Oral Uk-390,957 Administered As Required In Adult Men With Premature Ejaculation
- ClinicalTrials.gov ID
- NCT00219609
- Acronym / sponsor ID
- A3871028
- Conditions
- Ejaculation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,058 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (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.
To determine whether UK-390,957 is a safe treatment for premature ejaculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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)
- Subjects will have completed one of the phase 2 trials (A3871022/ A3871027/ A3871029) and will have met the diagnostic criteria for premature ejaculation as defined by DSM-IV
Key exclusion criteria (1 listed)
- No drug related serious adverse events
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 safety
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
Not yet recruiting
Male Pelvic Floor Muscle Rehabilitation Exercises
Erectile Dysfunction, Urinary Incontinence
RecruitingObservational study
Ejaculatory and Orgasmic Dysfunction Registry
Ejaculatory Dysfunction, Premature Ejaculation
Recruiting
Ejaculatory-Sparing HoLEP vs Standard HoLEP
Enlarged Prostate (BPH), Enlarged Prostate With Lower Urinary Tract Symptoms
RecruitingPhase 2
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)
Premature Ejaculation
Not yet recruitingPhase 2
Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
Premature Ejaculation
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
82 sites in 14 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 82 sites in 14 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 82 sites in United States, Canada, Australia, Israel, Germany and 9 more countries. 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 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.