Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation
|ClinicalTrials.gov Identifier: NCT02581826|
Recruitment Status : Unknown
Verified January 2016 by Cheng-Hsing Hsieh, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
Recruitment status was: Recruiting
First Posted : October 21, 2015
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Premature Ejaculation||Drug: Silodosin Drug: Placebo||Phase 2|
Premature Ejaculation (PE) is characterized as the most common sexual dysfunction in men with a prevalence of 21-33%. Based on the main theories about the pathophysiology of Premature Ejaculation (PE), the most commonly prescribed medications are topical anesthetics and serotonin-specific reuptake inhibitors (SSRIs). It has been reported that the abnormal ejaculation of semen is a typical but rather infrequent side effect of some α1-adrenoceptor antagonists. Silodosin had the highest selectivity for the vas deferens compared with other α1-adrenoceptor antagonists.
Patients suitable for inclusion in the baseline period were those who (as part of the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire) rated their perceived control over ejaculation as 'moderately difficult', 'very difficult' or 'extremely difficult', and the other four items as 'about half the time', 'more than half the time' or 'almost always or always'. Patients completed the Index of Premature Ejaculation (IPE) and Premature Ejaculation Profile (PEP) questionnaires, and rated the quality of their orgasm in response to the question: 'In general, how do you rate the orgasm you experience during sexual intercourse?' on a 5-point scale ('very poor', 'poor', 'satisfactory', 'good', 'very good'). Patients with a baseline Intravaginal Ejaculation Latency Time (IELT) of 2 minutes or less, as measured by a partner-held stopwatch, for at least two of the first three sexual encounters were eligible for randomization into the double-blind phase. In total of 40 eligible patients were randomized to receive double-blind treatment with 4 mg Silodosin or matched placebo for 3 months. One dose was to be taken 2 hours before anticipated sexual intercourse, and only one dose was allowed per 24-h period. Ejaculation-delaying techniques and behavioural therapy were to be avoided. Couples were instructed to attempt sexual intercourse four or more times per month during the 12-week treatment period (minimum of 24 h between doses of medication). During each sexual encounter, the Intravaginal Ejaculation Latency Time (IELT) was measured and recorded, together with efficacy and tolerability data. Ejaculation occurring before penetration was assigned an Intravaginal Ejaculation Latency Time (IELT) of 0 minute. The time noted on the stopwatch at this point was recorded as the duration of sexual intercourse until ejaculation or withdrawal. Patients returned to the clinic at 14-21 days intervals (visits 1, 2, 3, 4, 5 and 6) at which the Index of Premature Ejaculation (IPE) and Premature Ejaculation Profile (PEP) questionnaires were completed. Also, at visit 3 and 6 patients had a safety evaluation and rated the quality of their orgasms. Patients' satisfaction for the treatment was evaluated by Clinical Global Impression of Change (CGIC) in Premature Ejaculation (PE).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Silodosin
α1-adrenoceptor antagonists are distributed not only in the bladder neck, urethra, and prostate, but also in the seminal vesicle and vas deferens. Specifically, the distribution of messenger ribonucleic acid (mRNA) of α1-adrenoceptor antagonists in seminal vesicle and vas deferens is reported to be 75-97%. It is reasonable to use α1-adrenoceptor antagonists with high selectivity for patients with Premature Ejaculation (PE). A new highly selective α1-adrenoceptor antagonists, is strongly associated with dry ejaculation with loss of seminal emission. It had the highest selectivity for the vas deferens compared with other α1-adrenoceptor antagonists.The effectiveness of highly selective α1-adrenoceptor antagonists as a potential therapy for this class of patients was scarcely investigated.
Other Name: Urief
Placebo Comparator: Placebo
No column specified.
- Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: up to 12 weeks ]
- Erectile function domain of the International Index of Erectile Function (IIEF) [ Time Frame: Baseline ]
- Premature Ejaculation Diagnostic Tool (PEDT) [ Time Frame: Baseline ]
- Index of Premature Ejaculation (IPE) [ Time Frame: up to 12 weeks ]
- Premature Ejaculation Profile (PEP) [ Time Frame: up to 12 weeks ]
- Clinical Global Impression of Change (CGIC) [ Time Frame: up to 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581826
|Contact: Cheng-Hsing Hsieh, MD||+886-6628-9779 ext email@example.com|
|Contact: Jih-Rong Yang, MSc||+886-6628-9779 ext firstname.lastname@example.org|
|Taipei, Xindian, Taiwan, 23142|
|Contact: Jih-Rong Yang, MSc +886-6628-9779 ext 2240 email@example.com|
|Principal Investigator:||Cheng-Hsing Hsieh, MD||Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation|