Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation (Promescent)
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ClinicalTrials.gov Identifier: NCT02241460 |
Recruitment Status : Unknown
Verified September 2014 by Eugene Y Rhee, MD, Kaiser Permanente.
Recruitment status was: Enrolling by invitation
First Posted : September 16, 2014
Last Update Posted : September 16, 2014
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Condition or disease | Intervention/treatment | Phase |
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Premature Ejaculation | Drug: Placebo Drug: Promescent Lidocaine Spray | Phase 3 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241460
United States, California | |
Kaiser Permanente | |
Los Angeles, California, United States, 90027 | |
Kaiser Permanente | |
San Diego, California, United States, 92154 |
Principal Investigator: | Eugene Y Rhee, MD, MBA | Kaiser Permanente |
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 Key Record Dates |
Last Update Posted: | September 16, 2014 |
Last Verified: | September 2014 |
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