Clinical trial NCT03578783: PSD502 in Subjects With Premature Ejaculation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premature Ejaculation
Lead sponsor: Plethora Solutions Ltd
Sponsor class: INDUSTRY
First posted: 2018-07-06
Enrollment: 121
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change between Baseline and 4 weeks : Success on the Premature Ejaculation Bothersome Evaluation Questionnaire PEBEQ Item 3 (event-specific bother)
timeFrame: Baseline and 4 week treatment period
Secondary outcomes:
measure: Patient Global Impression of Change
timeFrame: 4 weeks post treatment
measure: Patient Global Impression of Severity
timeFrame: Baseline and 4 week treatment period
measure: Patient Global Impression of Change-Bother
timeFrame: 4 weeks post treatment
measure: Intravaginal ejaculatory latency time
timeFrame: Baseline and 4 week treatment period
measure: Independent Ejaculation Quickness Item
timeFrame: Baseline and 4 week treatment period
measure: Index of Premature Ejaculation Control Domain Score
timeFrame: 4 weeks post treatment
measure: Index of Premature Ejaculation Distress Domain Score
timeFrame: 4 weeks post treatment
measure: Index of Premature Ejaculation Satisfaction Domain Score
timeFrame: 4 weeks post treatment
measure: Independent Numeric Response Scale Bother Item
timeFrame: Baseline and 4 week treatment period
measure: Psychometric properties of the Premature Ejaculation Bothersome Evaluation Questionnaire Item 3 (event-specific bother)
timeFrame: 4 weeks post treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research
state: Alabama
city: Sherman Oaks
country: United States
facility: Skyline Urology
state: California
city: Boynton Beach
country: United States
facility: Imagine Research of Palm Beach County
state: Florida
city: Miami Lakes
country: United States
facility: Suncoast Research Associates
state: Florida
city: Miami
country: United States
facility: SunCoast Research
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Atlanta
country: United States
facility: Primary Care Research
state: Georgia
city: Lawrenceville
country: United States
facility: Georgia Clinical Research, Llc
state: Georgia
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Mens Health Boston
state: Massachusetts
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc
state: Nevada
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: Bala-Cynwyd
country: United States
facility: Midlantic Urology
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Advanced Clinical Research - Jordan Ridge Family Medicine
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
affiliation: Manhattan Medical Research, 215 Lexington Avenue, 21st Floor, New York, NY 10016
name: Jed Kaminetsky, MD, BA
role: PRINCIPAL_INVESTIGATOR
References: