Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation

Eugene Y Rhee, MD

Status and phase: Unknown; Phase 3

Conditions: Premature Ejaculation

Treatments: Drug: Promescent Lidocaine Spray; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02241460

Promescent

KPSC IRB 6428 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine Spray compared with placebo in patients with premature ejaculation.

Full description

Promescent Lidocaine Spray is a non-prescription drug that is marketed under an over-the-counter drug monograph (21 CFR Section 348.10 Subpart B (a)(2)) for male genital desensitizing drug products. In addition the evaluating the efficacy of treatment with Promescent, this study will evaluate patients' subjective distress, perception of improvement and optimal dose, and safety and tolerability of Promescent for patients with premature ejaculation and their respective partners.

Enrollment: 120 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Promescent Lidocaine Spray

Active Comparator group

Description:

Double-Blind Treatment Period: 3 cycles (3 weeks each); 1 week wash-out between each cycle Open-Label Treatment Period: 4 cycles (1 week each); no wash-out

Treatment:

Drug: Promescent Lidocaine Spray

Placebo

Placebo Comparator group

Description:

Double-Blind Treatment Period: 3 cycles (3 weeks each); 1 week wash-out between each cycle Open-Label Treatment Period: 4 cycles (1 week each); no wash-out

Treatment:

Drug: Promescent Lidocaine Spray

Drug: Placebo