Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature Ejaculation
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00219583
First received: September 9, 2005
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
Assessment of efficacy and safety UK-390,957.
| Condition | Intervention | Phase |
|---|---|---|
|
Ejaculation |
Drug: UK-390,957 |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase 2b, Multi-Centre, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study To Assess The Efficacy and Safety Of Oral UK390,957 In Men With Premature Ejaculation |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Assessment of efficacy and safety
Secondary Outcome Measures:
- Assessment of quality of sexual life
| Estimated Enrollment: | 460 |
| Study Start Date: | August 2004 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Premature ejaculation as defined by DSM-IV
Exclusion Criteria:
- History of erectile dysfunction
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00219583
Show 50 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219583
Show 50 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00219583 History of Changes |
| Other Study ID Numbers: | A3871027 |
| Study First Received: | September 9, 2005 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Premature Ejaculation Genital Diseases, Male Mental Disorders |
Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders |
ClinicalTrials.gov processed this record on March 01, 2015