Exploratory Study of Pagoclone in Men With Premature Ejaculation.
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.
1 other identifier
interventional
100
1 country
16
Brief Summary
The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2006
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 30, 2006
CompletedFirst Posted
Study publicly available on registry
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedDecember 27, 2013
February 1, 2007
Same day
August 30, 2006
December 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intravaginal ejaculation latency time (IELT)
Study Arms (4)
0.15 mg
EXPERIMENTAL0.30 mg
EXPERIMENTAL0.60 mg
EXPERIMENTALPBO
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- A male regularly experiencing premature ejaculation
- to 55 yrs old
- In a Stable relationship with one woman for at least 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Urology Centers of Alabama, PC
Homewood, Alabama, 35209, United States
SD Uro-Research
San Diego, California, 92103, United States
Urology Research Options
Aurora, Colorado, 80012, United States
Urology Associates, PC
Denver, Colorado, 80210, United States
Connecticut Clinical Research Center
Waterbury, Connecticut, 06708, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825, United States
Davis Clinic, PC
Indianapolis, Indiana, 46202, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
AccuMed Research Associates
Garden City, New York, 11530, United States
Urological Surgeons of Long Island, PC
Garden City, New York, 11530, United States
Center for Urologic Research of WNY
Williamsville, New York, 14221, United States
Metrolina Urology Clinic
Charlotte, North Carolina, 28207, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Johnny B. Roy, MD Private Practice
Edmond, Oklahoma, 73034, United States
Mobley Research Center
Houston, Texas, 77024, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2006
First Posted
September 1, 2006
Study Start
July 1, 2006
Primary Completion
July 1, 2006
Study Completion
October 1, 2006
Last Updated
December 27, 2013
Record last verified: 2007-02