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Exploratory Study of Pagoclone in Men With Premature Ejaculation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00370981
First received: August 30, 2006
Last updated: December 3, 2013
Last verified: February 2007
  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 Blind (Subject, 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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00370981     History of Changes
Other Study ID Numbers: IP456-040
Study First Received: August 30, 2006
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
investigational drug
ejaculation

Additional relevant MeSH terms:
Premature Ejaculation
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on November 19, 2014