Exploratory Study of Pagoclone in Men With Premature Ejaculation.
Primary Purpose
Premature Ejaculation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pagoclone
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation focused on measuring investigational drug, ejaculation
Eligibility 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
Sites / Locations
- Urology Centers of Alabama, PC
- SD Uro-Research
- Urology Research Options
- Urology Associates, PC
- Connecticut Clinical Research Center
- South Florida Medical Research
- Northeast Indiana Research, LLC
- Davis Clinic, PC
- Regional Urology, LLC
- AccuMed Research Associates
- Urological Surgeons of Long Island, PC
- Center for Urologic Research of WNY
- Metrolina Urology Clinic
- Wake Research Associates, LLC
- Johnny B. Roy, MD Private Practice
- Mobley Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
0.15 mg
0.30 mg
0.60 mg
PBO
Arm Description
Outcomes
Primary Outcome Measures
Intravaginal ejaculation latency time (IELT)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00370981
Brief Title
Exploratory Study of Pagoclone in Men With Premature Ejaculation.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
investigational drug, ejaculation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Arm Title
0.15 mg
Arm Type
Experimental
Arm Title
0.30 mg
Arm Type
Experimental
Arm Title
0.60 mg
Arm Type
Experimental
Arm Title
PBO
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pagoclone
Primary Outcome Measure Information:
Title
Intravaginal ejaculation latency time (IELT)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Urology Centers of Alabama, PC
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
SD Uro-Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Urology Research Options
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Urology Associates, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Connecticut Clinical Research Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Northeast Indiana Research, LLC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Davis Clinic, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Urological Surgeons of Long Island, PC
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Center for Urologic Research of WNY
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Metrolina Urology Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Johnny B. Roy, MD Private Practice
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Mobley Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
12. IPD Sharing Statement
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Exploratory Study of Pagoclone in Men With Premature Ejaculation.
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