PSD502 in Subjects With Premature Ejaculation



Status:Recruiting
Conditions:Premature Ejaculation, Women's Studies
Therapuetic Areas:Nephrology / Urology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:January 22, 2019
End Date:March 2020
Contact:Mike Failly, PhD
Email:Mike.Failly@premier-research.com
Phone:+33 1 44 50 30 20

Use our guide to learn which trials are right for you!

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

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.

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.

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.
We found this trial at
17
sites
Knoxville, Tennessee 37920
Principal Investigator: William Smith, MD
Phone: 865-305-9100
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Principal Investigator: Hayes Williams
Phone: 386-785-2408
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Principal Investigator: Bruce Rankin, DO CPI
Phone: 386-785-2408
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
?
mi
from
DeLand, FL
Click here to add this to my saved trials
Atlanta, Georgia 30342
Principal Investigator: Courtney Shelton
Phone: 407-788-8353
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Boynton Beach, Florida 33435
Principal Investigator: Grant Disick
Phone: 561-822-7007
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Jeffersonville, Indiana 47130
Principal Investigator: James Bailen, MD
Phone: 812-206-8161
?
mi
from
Jeffersonville, IN
Click here to add this to my saved trials
Las Vegas, Nevada 89106
Principal Investigator: Elliot Shin, MD
Phone: 702-631-5000
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Mobile, Alabama 36608
Principal Investigator: Charles White, MD
Phone: 251-414-1984
?
mi
from
Mobile, AL
Click here to add this to my saved trials
New York, New York 10016
Principal Investigator: Jed Kaminetsky, MD BA
Phone: 212-480-3333
?
mi
from
New York, NY
Click here to add this to my saved trials
Pompano Beach, Florida 33060
Principal Investigator: Craig Herman
Phone: 954-941-3330
?
mi
from
Pompano Beach, FL
Click here to add this to my saved trials
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Principal Investigator: Evan Goldfischer, MD
Phone: 845-437-5000
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
3100 Duraleigh Road
Raleigh, North Carolina 27612
Principal Investigator: Wayne Harper, MD
Phone: 919-781-2514
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Salt Lake City, Utah 84123
Principal Investigator: Johnson
Phone: 801-542-8190
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92120
Principal Investigator: Irwin Goldstein, MD
Phone: 619-265-8865
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Shreveport, Louisiana 71106
Principal Investigator: Jared Moss, MD
Phone: 318-683-0411
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Snellville, Georgia 30078
Principal Investigator: John Lentz
Phone: 678-822-5581
?
mi
from
Snellville, GA
Click here to add this to my saved trials
West Jordan, Utah 84088
Principal Investigator: Barbara Rizzardi
Phone: 801-542-8190
?
mi
from
West Jordan, UT
Click here to add this to my saved trials