Exploratory Study of Pagoclone in Men With Premature Ejaculation.

December 3, 2013 updated by: Endo Pharmaceuticals

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama, PC
    • California
      • San Diego, California, United States, 92103
        • SD Uro-Research
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Urology Research Options
      • Denver, Colorado, United States, 80210
        • Urology Associates, PC
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Connecticut Clinical Research Center
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Northeast Indiana Research, LLC
      • Indianapolis, Indiana, United States, 46202
        • Davis Clinic, PC
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
    • New York
      • Garden City, New York, United States, 11530
        • AccuMed Research Associates
      • Garden City, New York, United States, 11530
        • Urological Surgeons of Long Island, PC
      • Williamsville, New York, United States, 14221
        • Center for Urologic Research of WNY
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Metrolina Urology Clinic
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Johnny B. Roy, MD Private Practice
    • Texas
      • Houston, Texas, United States, 77024
        • Mobley Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PBO
Drug: pagoclone
Experimental: 0.15 mg
Drug: pagoclone
Experimental: 0.30 mg
Drug: pagoclone
Experimental: 0.60 mg
Drug: pagoclone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Intravaginal ejaculation latency time (IELT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

August 30, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimate)

September 1, 2006

Study Record Updates

Last Update Posted (Estimate)

December 27, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP456-040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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