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Exploratory Study of Pagoclone in Men With Premature Ejaculation.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370981
First Posted: September 1, 2006
Last Update Posted: December 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Endo Pharmaceuticals
  Purpose
The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.

Condition Intervention Phase
Premature Ejaculation Drug: pagoclone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Intravaginal ejaculation latency time (IELT)

Estimated Enrollment: 100
Study Start Date: July 2006
Study Completion Date: October 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.15 mg Drug: pagoclone
Experimental: 0.30 mg Drug: pagoclone
Experimental: 0.60 mg Drug: pagoclone
Placebo Comparator: PBO Drug: pagoclone

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370981


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

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00370981     History of Changes
Other Study ID Numbers: IP456-040
First Submitted: August 30, 2006
First Posted: September 1, 2006
Last Update Posted: December 27, 2013
Last Verified: February 2007

Keywords provided by Endo Pharmaceuticals:
investigational drug
ejaculation

Additional relevant MeSH terms:
Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders