Exploratory Study of Pagoclone in Men With Premature Ejaculation.

NCT ID: NCT00370981

Last Updated: 2013-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Premature Ejaculation

Keywords

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investigational drug ejaculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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0.15 mg

Group Type EXPERIMENTAL

pagoclone

Intervention Type DRUG

0.30 mg

Group Type EXPERIMENTAL

pagoclone

Intervention Type DRUG

0.60 mg

Group Type EXPERIMENTAL

pagoclone

Intervention Type DRUG

PBO

Group Type PLACEBO_COMPARATOR

pagoclone

Intervention Type DRUG

Interventions

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pagoclone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology Centers of Alabama, PC

Homewood, Alabama, United States

Site Status

SD Uro-Research

San Diego, California, United States

Site Status

Urology Research Options

Aurora, Colorado, United States

Site Status

Urology Associates, PC

Denver, Colorado, United States

Site Status

Connecticut Clinical Research Center

Waterbury, Connecticut, United States

Site Status

South Florida Medical Research

Aventura, Florida, United States

Site Status

Northeast Indiana Research, LLC

Fort Wayne, Indiana, United States

Site Status

Davis Clinic, PC

Indianapolis, Indiana, United States

Site Status

Regional Urology, LLC

Shreveport, Louisiana, United States

Site Status

AccuMed Research Associates

Garden City, New York, United States

Site Status

Urological Surgeons of Long Island, PC

Garden City, New York, United States

Site Status

Center for Urologic Research of WNY

Williamsville, New York, United States

Site Status

Metrolina Urology Clinic

Charlotte, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

Johnny B. Roy, MD Private Practice

Edmond, Oklahoma, United States

Site Status

Mobley Research Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IP456-040

Identifier Type: -

Identifier Source: org_study_id