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Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation

NCT00556478 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2016-09-26

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an attempt to delay ejaculation.

Conditions

  • Premature Ejaculation

Interventions

DRUG

PSD502, contains a mixture of lidocaine and prilocaine

PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis. Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue. During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period.

DRUG

Placebo

The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine. Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue. During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing. During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period.

Sponsors & Collaborators

  • Shionogi Inc.

    collaborator INDUSTRY

  • Plethora Solutions Ltd

    lead INDUSTRY

Principal Investigators

  • Culley Carson, MD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00556478 on ClinicalTrials.gov