Exploratory Study of Pagoclone in Men With Premature Ejaculation.

Phase 2

Completed

• Conditions: Premature Ejaculation
• Interventions: Drug: pagoclone

• Registration Number: NCT00370981
• Lead Sponsor: Endo Pharmaceuticals

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.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2006-07
• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-30
• Study First Posted: 2006-09-01
• Study Completion: 2006-10
• Status Verified: 2007-02
• Disposition First Submitted: 2013-12-03
• Disposition First Submitted QC: 2013-12-03
• Last Update Submitted: 2013-12-03
• Disposition First Posted: 2013-12-27
• Last Update Posted: 2013-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PBO	pagoclone	-
0.15 mg	pagoclone	-
0.60 mg	pagoclone	-
0.30 mg	pagoclone	-

Primary Outcome Measures

Name	Time	Method
Intravaginal ejaculation latency time (IELT)

Trial Locations

Locations (16)

Northeast Indiana Research, LLC; 🇺🇸 Fort Wayne, Indiana, United States

Regional Urology, LLC; 🇺🇸 Shreveport, Louisiana, United States

SD Uro-Research; 🇺🇸 San Diego, California, United States

Urology Associates, PC; 🇺🇸 Denver, Colorado, United States

Urology Centers of Alabama, PC; 🇺🇸 Homewood, Alabama, United States

Urology Research Options; 🇺🇸 Aurora, Colorado, United States

Connecticut Clinical Research Center; 🇺🇸 Waterbury, Connecticut, United States

South Florida Medical Research; 🇺🇸 Aventura, Florida, United States

Davis Clinic, PC; 🇺🇸 Indianapolis, Indiana, United States

AccuMed Research Associates; 🇺🇸 Garden City, New York, United States

Urological Surgeons of Long Island, PC; 🇺🇸 Garden City, New York, United States

Metrolina Urology Clinic; 🇺🇸 Charlotte, North Carolina, United States

Center for Urologic Research of WNY; 🇺🇸 Williamsville, New York, United States

Wake Research Associates, LLC; 🇺🇸 Raleigh, North Carolina, United States

Johnny B. Roy, MD Private Practice; 🇺🇸 Edmond, Oklahoma, United States

Mobley Research Center; 🇺🇸 Houston, Texas, United States