Exploratory Study of Pagoclone in Men With Premature Ejaculation.

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

Completed

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Key information

Conditions

Premature Ejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Urology Centers of Alabama, PC, Homewood, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pagoclone

Drug

Primary outcomes

Intravaginal ejaculation latency time (IELT)

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study 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.

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Sep 1, 2006
Registry last updated: Dec 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed