Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation

Inclusion Criteria:

• Subject has provided written informed consent before screening.

• Subject is a male, 18 years of age or older.

• Subject meets the diagnostic criteria for premature ejaculation as defined by theDSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, TextRevision; 2000).

• Subject has a stable, monogamous, heterosexual relationship and sexually active for atleast the last 6 months.

• Subject and partner are willing and able to engage in sexual intercourse.

Exclusion Criteria:

• Subject has never achieved an intravaginal ejaculation during the past 6 months (i.e.,always ejaculates prior to penetration).

• Subject has other forms of ejaculatory dysfunction (e.g., retrograde ejaculation,anejaculation, painful ejaculation).

• In the opinion of the investigator, the subject has a condition or is in a situationthat may put the subject at significant risk, may confound the study results, or mayinterfere significantly with the subject's ability to participate in the study.