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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Plethora Solutions Ltd
• Collaborator: Shionogi Inc.
• Treatments: Anesthetics; EMLA; Lidocaine; Lidocaine, Prilocaine Drug Combination; Prilocaine

Criteria

Inclusion Criteria:

• Willing and able to provide written informed consent.

• Male and aged 18 years and over.

• Diagnosed with PE according to DMS-IV criteria and ISSM definition

• Diagnosed with lifelong PE

• Acceptable response to Baseline PEP

• Subject must be in a stable heterosexual and monogamous relationship and the partner must provide consent

• Acceptable sexual encounters in the Baseline period.

Exclusion Criteria:

• Subject, or his sexual partner, has received an investigational (non-registered) drug within 30 days of Screening.

• Subject has erectile dysfunction

• The subject, or his sexual partner, has a physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following:

• Urological disease

• Ongoing significant psychiatric disorder not controlled by medication.

• Subject has safety testing abnormalities at the Screening Visit

• Subjects taking excluded medications or receiving any treatment for PE

• Subject, or his sexual partner, has a current history of alcohol or drug abuse,

• The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons.

• Subject, or his sexual partner, has known drug sensitivity to amide-type local anesthetics.

• Subjects with pregnant partners

• Subject with sexual partners of child-bearing potential and not using appropriate contraception

• Subject, or his sexual partner, has a history of Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g. anti-malarial agents).