256
Participants
Start Date
October 31, 2007
Primary Completion Date
October 31, 2009
Study Completion Date
October 31, 2009
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."
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."
Department of Urology, University of North Carolina, Chapel Hill
Lead Sponsor
Shionogi Inc.
INDUSTRY
Plethora Solutions Ltd
INDUSTRY