<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02241460</url>
  </required_header>
  <id_info>
    <org_study_id>Promescent</org_study_id>
    <secondary_id>KPSC IRB 6428</secondary_id>
    <nct_id>NCT02241460</nct_id>
  </id_info>
  <brief_title>Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation</brief_title>
  <acronym>Promescent</acronym>
  <official_title>A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eugene Y Rhee, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine&#xD;
      Spray compared with placebo in patients with premature ejaculation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Promescent Lidocaine Spray is a non-prescription drug that is marketed under an&#xD;
      over-the-counter drug monograph (21 CFR Section 348.10 Subpart B (a)(2)) for male genital&#xD;
      desensitizing drug products. In addition the evaluating the efficacy of treatment with&#xD;
      Promescent, this study will evaluate patients' subjective distress, perception of improvement&#xD;
      and optimal dose, and safety and tolerability of Promescent for patients with premature&#xD;
      ejaculation and their respective partners.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intravaginal Ejaculatory Latency Time (IELT) in seconds</measure>
    <time_frame>Week 11</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective distress</measure>
    <time_frame>Week 3, 7, and 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of improvement in premature ejaculation</measure>
    <time_frame>Week 3, 7, and 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived optimal dosage of treatment</measure>
    <time_frame>Week 3, 7, and 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events/reactions to treatments</measure>
    <time_frame>Week 11</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Premature Ejaculation</condition>
  <arm_group>
    <arm_group_label>Promescent Lidocaine Spray</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <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.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Promescent Lidocaine Spray</intervention_name>
    <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.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Promescent Lidocaine Spray</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided written informed consent before screening.&#xD;
&#xD;
          -  Subject is a male, 18 years of age or older.&#xD;
&#xD;
          -  Subject meets the diagnostic criteria for premature ejaculation as defined by the&#xD;
             DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text&#xD;
             Revision; 2000).&#xD;
&#xD;
          -  Subject has a stable, monogamous, heterosexual relationship and sexually active for at&#xD;
             least the last 6 months.&#xD;
&#xD;
          -  Subject and partner are willing and able to engage in sexual intercourse.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has never achieved an intravaginal ejaculation during the past 6 months (i.e.,&#xD;
             always ejaculates prior to penetration).&#xD;
&#xD;
          -  Subject has other forms of ejaculatory dysfunction (e.g., retrograde ejaculation,&#xD;
             anejaculation, painful ejaculation).&#xD;
&#xD;
          -  In the opinion of the investigator, the subject has a condition or is in a situation&#xD;
             that may put the subject at significant risk, may confound the study results, or may&#xD;
             interfere significantly with the subject's ability to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugene Y Rhee, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>May 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 12, 2014</last_update_submitted>
  <last_update_submitted_qc>September 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kaiser Permanente</investigator_affiliation>
    <investigator_full_name>Eugene Y Rhee, MD</investigator_full_name>
    <investigator_title>Chief, Department of Urologic Surgery</investigator_title>
  </responsible_party>
  <keyword>Premature Ejaculation</keyword>
  <keyword>Lidocaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Premature Ejaculation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02241460
org study id: Promescent
secondary id: KPSC IRB 6428
nct id: NCT02241460
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine
      Spray compared with placebo in patients with premature ejaculation.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Intravaginal Ejaculatory Latency Time (IELT) in seconds
time frame: Week 11
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.
measure: Subjective distress
time frame: Week 3, 7, and 11
measure: Perception of improvement in premature ejaculation
time frame: Week 3, 7, and 11
measure: Perceived optimal dosage of treatment
time frame: Week 3, 7, and 11
measure: Adverse events/reactions to treatments
time frame: Week 11
arm group label: Promescent Lidocaine Spray
arm group type: Active Comparator
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 group label: Placebo
arm group type: Placebo Comparator
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: Placebo
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.
arm group label: Placebo
intervention type: Drug
intervention name: Promescent Lidocaine Spray
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.
arm group label: Placebo
arm group label: Promescent Lidocaine Spray
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eugene Y Rhee, MD, MBA
role: Principal Investigator
affiliation: Kaiser Permanente
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Kaiser Permanente
investigator full name: Eugene Y Rhee, MD
investigator title: Chief, Department of Urologic Surgery
mesh term: Premature Birth
mesh term: Premature Ejaculation
mesh term: Lidocaine