Overview

Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation

Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine Spray compared with placebo in patients with premature ejaculation.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eugene Y Rhee, MD
Treatments:
Lidocaine
Criteria
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 the
DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text
Revision; 2000).

- Subject has a stable, monogamous, heterosexual relationship and sexually active for at
least 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 situation
that may put the subject at significant risk, may confound the study results, or may
interfere significantly with the subject's ability to participate in the study.