Exploratory Study of Pagoclone in Men With Premature Ejaculation.
This study has been completed.
Sponsor:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00370981
First received: August 30, 2006
Last updated: January 12, 2012
Last verified: February 2007
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Purpose
The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.
| Condition | Intervention | Phase |
|---|---|---|
|
Premature Ejaculation |
Drug: pagoclone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Four-arm, Randomized, Double-blind, Parallel, Placebo-controlled Exploratory Study of Pagoclone 0.15mg, 0.30mg, and 0.60mg in Men With Primary Premature Ejaculation. |
Further study details as provided by Endo Pharmaceuticals:
Primary Outcome Measures:
- Intravaginal ejaculation latency time (IELT)
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2006 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 0.15 mg | Drug: pagoclone |
| Experimental: 0.30 mg | Drug: pagoclone |
| Experimental: 0.60 mg | Drug: pagoclone |
| Placebo Comparator: PBO | Drug: pagoclone |
Detailed Description:
The primary objective of this study is to evaluate the effect of 3 dose levels of pagoclone (0.15 mg, 0.30 mg, and 0.60 mg) versus placebo on intravaginal ejaculation latency time (IELT) male patients with primary premature ejaculation.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A male regularly experiencing premature ejaculation
- 18 to 55 yrs old
- In a Stable relationship with one woman for at least 6 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370981
Locations
| United States, Alabama | |
| Urology Centers of Alabama, PC | |
| Homewood, Alabama, United States, 35209 | |
| United States, California | |
| SD Uro-Research | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| Urology Research Options | |
| Aurora, Colorado, United States, 80012 | |
| Urology Associates, PC | |
| Denver, Colorado, United States, 80210 | |
| United States, Connecticut | |
| Connecticut Clinical Research Center | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| South Florida Medical Research | |
| Aventura, Florida, United States, 33180 | |
| United States, Indiana | |
| Northeast Indiana Research, LLC | |
| Fort Wayne, Indiana, United States, 46825 | |
| Davis Clinic, PC | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Regional Urology, LLC | |
| Shreveport, Louisiana, United States, 71106 | |
| United States, New York | |
| AccuMed Research Associates | |
| Garden City, New York, United States, 11530 | |
| Urological Surgeons of Long Island, PC | |
| Garden City, New York, United States, 11530 | |
| Center for Urologic Research of WNY | |
| Williamsville, New York, United States, 14221 | |
| United States, North Carolina | |
| Metrolina Urology Clinic | |
| Charlotte, North Carolina, United States, 28207 | |
| Wake Research Associates, LLC | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Oklahoma | |
| Johnny B. Roy, MD Private Practice | |
| Edmond, Oklahoma, United States, 73034 | |
| United States, Texas | |
| Mobley Research Center | |
| Houston, Texas, United States, 77024 | |
Sponsors and Collaborators
Endo Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00370981 History of Changes |
| Other Study ID Numbers: | IP456-040 |
| Study First Received: | August 30, 2006 |
| Last Updated: | January 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endo Pharmaceuticals:
|
investigational drug ejaculation |
Additional relevant MeSH terms:
|
Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013