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PSD502 in Subjects With Premature Ejaculation

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ClinicalTrials.gov Identifier: NCT03578783
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Plethora Solutions Ltd

Brief Summary:
This study is being done to test the effect of PSD502 (the study medication) compared to placebo in subjects with premature ejaculation. PSD502 is a topical (applied to skin) anesthetic spray containing a mixture of two drugs called lidocaine and prilocaine that will be applied to the penis. Half of the subjects will receive PSD502 and half will receive placebo.

Condition or disease Intervention/treatment Phase
Premature Ejaculation Drug: Placebo Drug: PSD502 Phase 2

Detailed Description:

The study will assess whether the bothersome symptoms of premature ejaculation (PE) are helped when treated with PSD502 by answering questionnaires such as the 'Premature Ejaculation Bothersome Evaluation Questionnaire' (PEBEQ) and 'Index of Premature Ejaculation© (IPE) and some additional questions about premature ejaculation.

The study will also measure the effect of PSD502 on the Intravaginal Ejaculatory Latency Time (IELT). This is the time between when the penis enters the vagina and when the subject starts to ejaculate in the vagina.

Subjects are stratified based on whether they are circumcised or uncircumcised and within each stratified group subjects are randomized to PSD502 (lidocaine prilocaine spray) or placebo in a 1:1 ratio.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Multicenter, Randomized, Double-Blind Study Comparing The Proportion Of Responders to PSD502 and to Placebo Using the PEBEQ In Subjects With Premature Ejaculation
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: PSD502
PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis.
Drug: PSD502

For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration.

Study subjects should leave at least 24 hours between each dosing.


Placebo Comparator: Placebo
The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone).
Drug: Placebo

For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration.

Study subjects should leave at least 24 hours between each dosing.





Primary Outcome Measures :
  1. Change between Baseline and 4 weeks : Success on the Premature Ejaculation Bothersome Evaluation Questionnaire PEBEQ Item 3 (event-specific bother) [ Time Frame: Baseline and 4 week treatment period ]
    Success is defined as having a 1-point or greater improvement between the mean response over the treatment period and the mean response during the baseline period


Secondary Outcome Measures :
  1. Patient Global Impression of Change [ Time Frame: 4 weeks post treatment ]
    Patient-reported global impression of change in the quickness of their ejaculation. Subjects will be asked to provide a response to the question 'Compared to when you started the study, how would you describe any change in how quickly you ejaculate now?' on a 7-point scale of: 'A great deal better', 'Moderately better', 'A little better', 'About the same', 'A little worse', 'Moderately worse' and 'A great deal worse'. Subjects will also be asked to provide a 'Yes' or 'No' response to the question 'Was this a meaningful or important change for you?'

  2. Patient Global Impression of Severity [ Time Frame: Baseline and 4 week treatment period ]
    Change from baseline in patient-reported impression of severity of the quickness of their ejaculation.Subjects will be asked to answer the question 'Overall, how severe is the quickness of your ejaculation?' using a 5-point scale of 'Not Severe', 'Mildly Severe', 'Moderately Severe', 'Very Severe' and 'Extremely Severe'.

  3. Patient Global Impression of Change-Bother [ Time Frame: 4 weeks post treatment ]
    Patient-reported global impression of change in the bother resulting from the quickness of their ejaculation. Subjects will be asked to provide a response to the following question 'Compared to when you started the study, how would you describe any change in how much you are bothered by the quickness of your ejaculation now?' on a 7-point scale of: 'Bothered a great deal less', 'Bothered moderately less', 'Bothered a little less', 'Bothered about the same', 'Bothered a little worse', 'Bothered moderately worse' and 'Bothered a great deal worse'. Subjects will also be asked to provide a 'Yes' or 'No' response to the question 'Was this a meaningful or important change for you?'.

  4. Intravaginal ejaculatory latency time [ Time Frame: Baseline and 4 week treatment period ]
    Change from baseline in intravaginal ejaculatory latency time

  5. Independent Ejaculation Quickness Item [ Time Frame: Baseline and 4 week treatment period ]
    Change from baseline in patient-reported impression of how quickly they ejaculated during each attempt of sexual intercourse

  6. Index of Premature Ejaculation Control Domain Score [ Time Frame: 4 weeks post treatment ]
    Change from baseline in the Index of Premature Ejaculation Control Domain Score. The domain is based on 4 items (score range 4-20). Low scores represent a worse value.

  7. Index of Premature Ejaculation Distress Domain Score [ Time Frame: 4 weeks post treatment ]
    Change from baseline in the Index of Premature Ejaculation Distress Domain Score. The domain is based on two items (score range 2-10). Low scores represent a worse value.

  8. Index of Premature Ejaculation Satisfaction Domain Score [ Time Frame: 4 weeks post treatment ]
    Change from baseline in the Index of Premature Ejaculation Satisfaction Domain Score. The domain is based on 4 items (score range 4-20). Low scores represent a worse value.

  9. Independent Numeric Response Scale Bother Item [ Time Frame: Baseline and 4 week treatment period ]
    Change from baseline in patient-reported assessment of bother during each attempt of sexual intercourse

  10. Psychometric properties of the Premature Ejaculation Bothersome Evaluation Questionnaire Item 3 (event-specific bother) [ Time Frame: 4 weeks post treatment ]
    Patient-reported impression of how bothered they were by how quickly they ejaculated during each attempt of sexual intercourse. Subjects will be asked to provide a response to the question 'How bothered were you by how quickly you ejaculated during the sexual intercourse you just engaged in?' on a 5-point scale of 'Not at All', 'A Little Bit', 'Moderately', 'Quite a Bit' and 'Extremely'



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Male and aged 18 years and over.
  • Diagnosed with PE according to the ISSM definition, that is, he ejaculates always or nearly always prior to or within about one minute of vaginal penetration; and is unable to delay ejaculation on all or nearly all vaginal penetrations; and experiences negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.
  • Subject has lifelong PE from the first sexual experience.
  • Subject must be in a stable heterosexual and monogamous relationship of at least 3 months' duration with this partner.
  • Subject has at least documented 3 sexual encounters, each separated by an interval of at least 24 hours, in the baseline period.
  • IELT ≤1 minute in all sexual encounters in the baseline period.
  • The subject's partner must provide written informed consent, be aged 18 years or over and willing to comply with the study procedures.
  • Subject indicates a level of Bother on Item 3 of the PEBEQ of either "moderately", "quite a bit" or "extremely" on all encounters during the baseline period.
  • Subject registers a level of "bother" at a score of 4 or greater on an 11-point NRS scale at Screening to ensure that subjects not bothered by the quickness of their ejaculation are not entered into the baseline period.

Exclusion Criteria:

  • Subject, or his sexual partner, has received an investigational (unapproved) drug within 30 days of Screening.
  • Subject has erectile dysfunction, defined as an IIEF-5 score of 21, unless the low score is entirely related to PE symptoms in the opinion of the Investigator.
  • The subject, or his sexual partner, has a physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following:

    1. Urological disease (e.g., prostatitis, urinary tract infection) or genitourinary surgery within 8 weeks of Screening.
    2. Ongoing significant psychiatric disorder (e.g., bipolar disease, depression / anxiety disorder or schizophrenia) not controlled by medication.
  • Subject has safety testing abnormalities at the Screening Visit, in particular liver function tests or anemia, that are indicative of a medical condition that would preclude further participation in the opinion of the Investigator.
  • Subjects taking tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs), for indications other than PE, where the dose has been changed within 4 weeks of Screening or it is planned that the dose will change during the treatment period.
  • Subject has received any treatment for PE e.g., anti-depressant therapy, local anesthetic spray, eutectic mixture of local anesthetics (EMLA®) cream, intra-cavernosal injection, tramadol or psychotherapy within 4 weeks of Screening
  • Subject, or his sexual partner, has a current history of alcohol or drug abuse, in the opinion of the Investigator.
  • The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons.
  • Subject, or his sexual partner, has known drug sensitivity to amide-type local anesthetics.
  • Subjects with pregnant partners.
  • Subject with sexual partners of child-bearing potential and not using appropriate contraception (hormonal contraception or intra-uterine device [IUD]).
  • Subject, or his sexual partner, has a history of glucose-6-phosphate dehydrogenase (G 6 PD) deficiency or currently using medications that would increase susceptibility to methemoglobinemia (e.g., anti-malarial agents) or has congenital or acquired methemoglobinemia, or is at risk of industrial exposure to agents causing methemoglobinemia.
  • Subject, or his sexual partner, uses Class I (e.g., mexiletine, tocainide) or III (e.g., amiodarone, sotalol) anti-arrhythmic drugs, or cimetidine, beta blockers or local anesthetics.
  • Subject has received PSD502 in a clinical study or has received Fortacin within 1 year of Screening.

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): NCT03578783


Contacts
Contact: Mike Failly, PhD +33 1 44 50 30 20 Mike.Failly@premier-research.com

Locations
United States, Alabama
Coastal Clinical Research Not yet recruiting
Mobile, Alabama, United States, 36608
Contact: Charles White, MD    251-414-1984    cwhite@ccr-research.com   
Principal Investigator: Charles White, MD         
United States, California
San Diego Sexual Medicine, APC Not yet recruiting
San Diego, California, United States, 92120
Contact: Irwin Goldstein, MD    619-265-8865    dr.irwingoldstein@gmail.com   
Principal Investigator: Irwin Goldstein, MD         
United States, Florida
Avail Clinical Research Not yet recruiting
DeLand, Florida, United States, 32720
Contact: Bruce Rankin, DO CPI    386-785-2408    brankin@accelclinical.com   
Principal Investigator: Bruce Rankin, DO CPI         
United States, Indiana
First Urology Not yet recruiting
Jeffersonville, Indiana, United States, 47130
Contact: James Bailen, MD    812-206-8161    jbailen@1sturology.com   
Principal Investigator: James Bailen, MD         
United States, Louisiana
Regional Urology, LLC Not yet recruiting
Shreveport, Louisiana, United States, 71106
Contact: Jared Moss, MD    318-683-0411    jmoss@regionalurology.com   
Principal Investigator: Jared Moss, MD         
United States, Missouri
Center For Pharmaceutical Research Not yet recruiting
Kansas City, Missouri, United States, 64114
Contact: John Ervin, MD FACP FACR    816-943-0770    newstudy@cprkc.com   
Principal Investigator: John Ervin, MD FACP FACR         
United States, New York
Manhattan Medical Research Practice Recruiting
New York, New York, United States, 10016
Contact: Jed Kaminetsky, MD BA    212-480-3333    jed.kaminetsky@nyumc.com   
Principal Investigator: Jed Kaminetsky, MD BA         
Premier Medical Group of the Hudson Valley Not yet recruiting
Poughkeepsie, New York, United States, 12601
Contact: Evan Goldfischer, MD    845-437-5000    evanrgold@gmail.com   
Principal Investigator: Evan Goldfischer, MD         
United States, North Carolina
M3 Wake Research, Inc Not yet recruiting
Raleigh, North Carolina, United States, 27612
Contact: Wayne Harper, MD    919-781-2514    wharper@wakeresearch.com   
Principal Investigator: Wayne Harper, MD         
United States, Tennessee
Volunteer Research Group Not yet recruiting
Knoxville, Tennessee, United States, 37920
Contact: William Smith, MD    865-305-9100    wbsmd@noccr.com   
Principal Investigator: William Smith, MD         
Sponsors and Collaborators
Plethora Solutions Ltd
Investigators
Principal Investigator: Jed Kaminetsky, MD, BA Manhattan Medical Research, 215 Lexington Avenue, 21st Floor, New York, NY 10016

Responsible Party: Plethora Solutions Ltd
ClinicalTrials.gov Identifier: NCT03578783     History of Changes
Other Study ID Numbers: PSD502-PE-008
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
EMLA
Lidocaine
Prilocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Combined
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action