premature ejaculation
Conditions
Interventions
Group 1:Dapoxetine 30 mg on demand
Group 2:Regular penis-root masturbatory training, three times a week, 10-15min per time
Group 3:Regular penis-root masturbatory training combines with Dapoxetine 30 mg on demand
Sponsors
The Third Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Men between the ages of 18 and 40 years; 2. PE defined by the 2014 ISSM criteria: A male sexual dysfunction characterized by the following: (1) Ejaculation that always or nearly always occurs prior to or within about 1 minute of vaginal penetration (lifelong PE) or a clinically significant and bothersome reduction in latency time, often to about 3 minutes or less (acquired PE); (2) The inability to delay ejaculation on all or nearly all vaginal penetrations; (3) Negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy; 3. A stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two intercourses a week, and keep this relationship stable during the study period; 4. Premature Ejaculation Diagnostic Tool (PEDT) score >=9 (Chinese men)or >=11 (Italian Men); 5. The patient who are willing to sign the informed consent form and be followed up monthly.
Exclusion criteria
Exclusion criteria: 1. Variable PE or subjective PE; 2. Homosexual, bisexual or paraphilic patients; 3. Use of SSRIs, TCAs, and PDE5-Is or other medications potentially interfering with dapoxetine; 4. Erectile dysfunction (ED) as determined by the International Index of Erectile Function (IIEF-15), EF domain score <26; 5. Use of medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases; 6. Patients with sex hormone abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infection; 7. Combined with depression or anxiety, manic episodes, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, schizophrenia or other psychotic disorders; 8. Abuse of alcohol or use of illegal drugs; 9. A history of dorsal penile nerve amputation surgery; 10. With history of any previous therapies for PE, or stop the therapies for at least 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intravaginal Ejaculatory Latency Time (IELT);Premature Ejaculation Diagnostic Tool (Total Score); | — |
Secondary
| Measure | Time frame |
|---|---|
| The Clinical Global Impression Scale (CGII);Male Orgasmometer; | — |
Countries
Italy
Contacts
Public ContactYan Zhang
The Third Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed