Primary Premature Ejaculation
Conditions
Interventions
Experimental group:Approximately 5 minutes prior to intercourse, the study drug PSD502 is sprayed onto the glans (single dose, total of 3 spray)
Placebo group:Approximately 5 minutes prior to intercourse, the placebo is sprayed onto the glans (single dose, total of 3 spray)
Sponsors
The Third Hospital of Peking University
Eligibility
Sex/Gender
Male
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: A subject will be considered suitable for the study if he fulfills all of the following criteria: 1. Willing and able to provide written informed consent. 2. Male and aged 20 years and over. 3. 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. 4. Subject response to Screening visit 1 PEP as follows: (1) Perceived control over ejaculation of Poor or Very poor; (2) Personal distress related to ejaculation of 'Quite a bit' or 'Extremely' (3) Interpersonal difficulty related to ejaculation of 'Quite a bit' or 'Extremely' (4) Satisfaction with the sexual intercourse of 'Poor' or 'Very poor'. 5. Subject has at least documented 3 sexual encounters in the Baseline period. 6. IELT <= 1 minute in at least 2 of the first 3 sexual encounters in the Baseline period. 7. The subject's partner must provide written informed consent, be aged 20 years or over, and willing to comply with the study procedures. 8. Subject must be in a stable relationship with this sexual partner during the study.
Exclusion criteria
Exclusion criteria: A subject, or his sexual partner where stated, who fulfils any of the following criteria will be excluded from the study: 1. Subject is in a unstable heterosexual relationship or stable relationship less than 3 months. 2. Subject, or his sexual partner, has received an investigational (non-registered) drug within 30 days of Screening. 3. Subject has erectile dysfunction, defined as an IIEF5 score of 2 UNL, creatinine>20% of UNL), that are indicative of a medical condition that would preclude further participation in the opinion of the Investigator. 6. Subject has received any treatment for PE e.g. dapoxetine hydrochloride tablets, anti-depressant therapy, local anesthetic spray, intra-cavernosal injection or psychotherapy within 4 weeks of Screening. 7. Subject, or his sexual partner, has a current history of alcohol or drug abuse, in the opinion of the Investigator. 8. The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons. 9. Subject or his sexual partner has known drug sensitivity to amide-type local anesthetics. 10. Subjects with pregnant partners. 11. Subject with sexual partners of child-bearing potential and not using appropriate contraception (Appropriate contraception refers to the use of hormonal contraception or intrauterine devices (IUDs) or other female contraceptives (e.g., liquid gels, female condoms (non-polyurethane) in the double-blind portion of the study) 12. Subject, or his sexual partner, has a history of Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g. anti-malarial agents). 13. Subject, or his sexual partner, uses class I (e.g. mexiletine, tocainide) or III (e.g. amiodarone, sotalol) anti-arrhythmic drugs. 14. Subjects judged by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean IELT from Baseline to during the 3 months of double-blind treatment;Change in the IPE domain of ejaculatory control from Baseline to month 3;Change in the IPE domain of sexual satisfaction from Baseline to month 3;Change in the IPE domain of distress from Baseline to month 3; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mean IELT >1 minute during the 3 months of double-blind treatment;Proportion of subjects with mean IELT >2 minutes during the 3 months of double-blind treatment;Change in mean IELT from Baseline to each month of double-blind treatment;Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to months 1 and 2 separately;Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at months 1, 2 and 3;Change in scores of PEDT of subjects at months 1,2 and 3;Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the PEP of sexual partner of subject at months 3; | — |
Countries
China
Contacts
Public ContactHui Jiang
Peking University Third Hospital
Outcome results
None listed