ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
Eugene Y Rhee, MD, Kaiser Permanente

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 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

Resource links provided by the National Library of Medicine


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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

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


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

Responsible Party: Eugene Y Rhee, MD, Chief, Department of Urologic Surgery, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02241460     History of Changes
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

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