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Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation

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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
Sponsor:
Information provided by (Responsible Party):
Cheng-Hsing Hsieh, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Tracking Information
First Submitted Date  ICMJE October 15, 2015
First Posted Date  ICMJE October 21, 2015
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: up to 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02581826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation
Official Title  ICMJE Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Brief Summary The objectives of the present study aims to evaluate the safety and efficacy of Silodosin in a population of patients wih Premature Ejaculation (PE). Coupled with efficient diagnosis, it is hoped that the newer agent will improve the quality of life for patients who suffer from Premature Ejaculation (PE).
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Premature Ejaculation
Intervention  ICMJE
  • Drug: 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
  • Drug: Placebo
    No column specified.
Study Arms  ICMJE
  • Active Comparator: Silodosin
    1. Silodosin capsules of 4 mg, oral: 4 mg once daily with a meal, total dosage 12 mg for 14-21 days.
    2. This arm received Silodosin in the first intervention period and Placebo in the second period (after washout period of 14-21 days).
    3. The patients received 4 mg of Silodosin 1 times a day, total dosage 12 mg for 14-21 days.
    Intervention: Drug: Silodosin
  • Placebo Comparator: Placebo
    1. Placebo capsules of 4 mg, oral: 4 mg once daily with a meal, total dosage 12 mg for 14-21 days.
    2. This arm received Placebo in the first period and Silodosin in the second period (after washout period of 14-21 days).
    3. The patients received 4 mg of Placebo 1 times a day, total dosage 12 mg for 14-21 days.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 19, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02581826
Other Study ID Numbers  ICMJE 01-X15-058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cheng-Hsing Hsieh, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study Sponsor  ICMJE Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheng-Hsing Hsieh, MD Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
PRS Account Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP