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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

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."

Trial Locations (1)

27599 - 7254

Department of Urology, University of North Carolina, Chapel Hill

Sponsors
All Listed Sponsors
collaborator

Shionogi Inc.

INDUSTRY

lead

Plethora Solutions Ltd

INDUSTRY

NCT00556478 - Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation | Biotech Hunter | Biotech Hunter