Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation

NCT02241460 | Unknown Phase 3 DMC

• 2 other identifiers: PromescentKPSC IRB 6428
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Premature Ejaculation

Keywords

Premature Ejaculation; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Intravaginal Ejaculatory Latency Time (IELT) in seconds

  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.

  Week 11

Secondary Outcomes (4)

• Subjective distress

  Week 3, 7, and 11

• Perception of improvement in premature ejaculation

  Week 3, 7, and 11

• Perceived optimal dosage of treatment

  Week 3, 7, and 11

• Adverse events/reactions to treatments

  Week 11

Study Arms (2)

Promescent Lidocaine Spray

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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; Drug: Promescent Lidocaine Spray

Interventions

Placebo DRUG

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.

Placebo

Promescent Lidocaine Spray DRUG

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; Promescent Lidocaine Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eugene Y Rhee, MD: lead

Study Sites (2)

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

Kaiser Permanente

San Diego, California, 92154, United States

Location

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Eugene Y Rhee, MD, MBA

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Department of Urologic Surgery

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: September 16, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

US (2)