Exploratory Study of Pagoclone in Men With Premature Ejaculation.

Premature Ejaculation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370981
• Other study ID #: IP456-040
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2006
• Last updated: December 3, 2013
• Start date: July 2006
• Est. completion date: October 2006

Study information

• Verified date: February 2007
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• pagoclone

Locations

Country	Name	City	State
United States	Urology Research Options	Aurora	Colorado
United States	South Florida Medical Research	Aventura	Florida
United States	Metrolina Urology Clinic	Charlotte	North Carolina
United States	Urology Associates, PC	Denver	Colorado
United States	Johnny B. Roy, MD Private Practice	Edmond	Oklahoma
United States	Northeast Indiana Research, LLC	Fort Wayne	Indiana
United States	AccuMed Research Associates	Garden City	New York
United States	Urological Surgeons of Long Island, PC	Garden City	New York
United States	Urology Centers of Alabama, PC	Homewood	Alabama
United States	Mobley Research Center	Houston	Texas
United States	Davis Clinic, PC	Indianapolis	Indiana
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	SD Uro-Research	San Diego	California
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Connecticut Clinical Research Center	Waterbury	Connecticut
United States	Center for Urologic Research of WNY	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravaginal ejaculation latency time (IELT)