Eligibility criteria
Condition
Ejaculation
Sex
Male
Age
18 + years
Inclusion criteria
Show details
- Premature ejaculation as defined by DSM-IV
Exclusion criteria
Show details
- History of erectile dysfunction
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Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation
NCT00143117
Last updated on October 13, 2019
About this Study
To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation.
NCT00143117
Pfizer
Completed
Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation | |||
| Official Title ICMJE | A Phase 2b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study to Assess the Efficacy and Safety of Oral UK-390,957 in Men With Premature Ejaculation | |||
| Brief Summary | To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Ejaculation | |||
| Intervention ICMJE | Drug: UK-390,957 | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 460 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | June 2005 | |||
| Actual Primary Completion Date | June 2005 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00143117 | |||
| Other Study ID Numbers ICMJE | A3871022 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | November 2012 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
BY PHONE
Pfizer Clinical Trials Contact Center
1-800-718-1021