PSD502 in Subjects With Premature Ejaculation

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:

• Urological disease (e.g., prostatitis, urinary tract infection) or genitourinary surgery within 8 weeks of Screening.
• 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.