Back to resultsEfficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation (Promescent)
Primary Purpose
Premature Ejaculation
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Promescent Lidocaine Spray
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation focused on measuring Premature Ejaculation, Lidocaine
Eligibility 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.
Sites / Locations
- Kaiser Permanente
- Kaiser Permanente
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Promescent Lidocaine Spray
Placebo
Arm 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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Subjective distress
Perception of improvement in premature ejaculation
Perceived optimal dosage of treatment
Adverse events/reactions to treatments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02241460
Brief Title
Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation
Acronym
Promescent
Official Title
A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eugene Y Rhee, MD
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
Premature Ejaculation, Lidocaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Promescent Lidocaine Spray
Arm Type
Active Comparator
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Promescent Lidocaine Spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intravaginal Ejaculatory Latency Time (IELT) in seconds
Description
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.
Time Frame
Week 11
Secondary Outcome Measure Information:
Title
Subjective distress
Time Frame
Week 3, 7, and 11
Title
Perception of improvement in premature ejaculation
Time Frame
Week 3, 7, and 11
Title
Perceived optimal dosage of treatment
Time Frame
Week 3, 7, and 11
Title
Adverse events/reactions to treatments
Time Frame
Week 11
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Y Rhee, MD, MBA
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation
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