Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation (Promescent)

• ClinicalTrials.gov Identifier: NCT02241460
• Recruitment Status: Unknown
• First Posted: September 16, 2014
• Last Update Posted: September 16, 2014
• Sponsor: Eugene Y Rhee, MD
• Information provided by (Responsible Party): Eugene Y Rhee, MD, Kaiser Permanente

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Premature Ejaculation	Drug: Placebo; Drug: Promescent Lidocaine Spray	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation
• Study Start Date: March 2014
• Estimated Primary Completion Date: December 2015
• Estimated Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Promescent Lidocaine Spray; 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	Drug: Promescent Lidocaine Spray; During the Double-Blind Treatment Period, patients randomized to active treatment will receive three cycles of Promescent. The first and second cycle consists of three weeks of treatment using 30 mg and 50 mg, followed by one week of washout. The third cycle consists of three weeks of treatment using 70 mg, followed by four weeks of treatment during the Open-Label Treatment Period using patient's self-selected dose.
Placebo Comparator: Placebo; 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	Drug: Placebo; During the Double-Blind Treatment Period, patients randomized to placebo will receive three cycles of Promescent. The first and second cycle consists of three weeks of treatment using 30 mg and 50 mg, followed by one week of washout. The third cycle consists of three weeks of treatment using 70 mg. During the Open-Label Treatment Period, the patient will receive four weeks of Promescent (active treatment) in one-week cycles: 30 mg, 50 mg, 70 mg, and patient's self-selected dose.; Drug: Promescent Lidocaine Spray; During the Double-Blind Treatment Period, patients randomized to active treatment will receive three cycles of Promescent. The first and second cycle consists of three weeks of treatment using 30 mg and 50 mg, followed by one week of washout. The third cycle consists of three weeks of treatment using 70 mg, followed by four weeks of treatment during the Open-Label Treatment Period using patient's self-selected dose.

Outcome Measures

Primary Outcome Measures :

1. Intravaginal Ejaculatory Latency Time (IELT) in seconds [ Time Frame: Week 11 ]
   The primary efficacy outcome is the proportion of subjects that achieve a mean IELT of greater than 90 seconds at Week 3, 7, and 11.

Secondary Outcome Measures :

1. Subjective distress [ Time Frame: Week 3, 7, and 11 ]
2. Perception of improvement in premature ejaculation [ Time Frame: Week 3, 7, and 11 ]
3. Perceived optimal dosage of treatment [ Time Frame: Week 3, 7, and 11 ]
4. Adverse events/reactions to treatments [ Time Frame: Week 11 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Kaiser Permanente

Los Angeles, California, United States, 90027

Kaiser Permanente

San Diego, California, United States, 92154

Sponsors and Collaborators

Eugene Y Rhee, MD

Investigators

• Principal Investigator: Eugene Y Rhee, MD, MBA; Kaiser Permanente

More Information

• Responsible Party: Eugene Y Rhee, MD, Chief, Department of Urologic Surgery, Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT02241460
• Other Study ID Numbers: Promescent; KPSC IRB 6428 ( Other Identifier: Kaiser Permanente Southern California Institutional Review Board )
• First Posted: September 16, 2014
• Last Update Posted: September 16, 2014
• Last Verified: September 2014

Keywords provided by Eugene Y Rhee, MD, Kaiser Permanente:

Premature Ejaculation; Lidocaine

Additional relevant MeSH terms:

Premature Birth; Premature Ejaculation; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Sexual Dysfunction, Physiological; Genital Diseases, Male; Sexual Dysfunctions, Psychological; Mental Disorders; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action