Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation
Premature Ejaculation
About this trial
This is an interventional treatment trial for Premature Ejaculation
Eligibility Criteria
Inclusion Criteria:
- Premature Ejaculation (PE) diagnosed by Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) criteria.
- Stable heterosexual, monogamous relationships more than 3 months.
- Age of 20 years or order.
- Written informed consent.
Exclusion Criteria:
- α1-adrenoceptor antagonists within 4 weeks.
- Erectile dysfunction (ED) defined by an Index of Erectile Function (IIEF-5) score < 21.
- History of physical or psychological disorder (patient or partner).
- Patient need to adjust dosage during the screening and treatment period, including tricyclic antidepressants, monoamine oxidase inhibitors or selective serotonin reuptake inhibitors (SSRIs).
- Antidepressant therapy, local anaesthetic spray, intracavernosal injection or psychotherapy within 4 weeks.
- History of alcohol or drug abuse.
- Pregnant partners.
Sites / Locations
- Cheng-Hsing HsiehRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Silodosin
Placebo
Silodosin capsules of 4 mg, oral: 4 mg once daily with a meal, total dosage 12 mg for 14-21 days. This arm received Silodosin in the first intervention period and Placebo in the second period (after washout period of 14-21 days). The patients received 4 mg of Silodosin 1 times a day, total dosage 12 mg for 14-21 days.
Placebo capsules of 4 mg, oral: 4 mg once daily with a meal, total dosage 12 mg for 14-21 days. This arm received Placebo in the first period and Silodosin in the second period (after washout period of 14-21 days). The patients received 4 mg of Placebo 1 times a day, total dosage 12 mg for 14-21 days.