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Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation

Primary Purpose

Premature Ejaculation

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Silodosin
Placebo
Sponsored by
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Silodosin

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Intravaginal Ejaculatory Latency Time (IELT)

Secondary Outcome Measures

Erectile function domain of the International Index of Erectile Function (IIEF)
Premature Ejaculation Diagnostic Tool (PEDT)
Index of Premature Ejaculation (IPE)
Premature Ejaculation Profile (PEP)
Clinical Global Impression of Change (CGIC)

Full Information

First Posted
October 15, 2015
Last Updated
January 3, 2016
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02581826
Brief Title
Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation
Official Title
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silodosin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Silodosin
Other Intervention Name(s)
Urief
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
No column specified.
Primary Outcome Measure Information:
Title
Intravaginal Ejaculatory Latency Time (IELT)
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Erectile function domain of the International Index of Erectile Function (IIEF)
Time Frame
Baseline
Title
Premature Ejaculation Diagnostic Tool (PEDT)
Time Frame
Baseline
Title
Index of Premature Ejaculation (IPE)
Time Frame
up to 12 weeks
Title
Premature Ejaculation Profile (PEP)
Time Frame
up to 12 weeks
Title
Clinical Global Impression of Change (CGIC)
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng-Hsing Hsieh, MD
Phone
+886-6628-9779
Ext
2240
Email
kevinchhsieh@tzuchi.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Jih-Rong Yang, MSc
Phone
+886-6628-9779
Ext
2240
Email
xdb05251@tzuchi.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Hsing Hsieh, MD
Organizational Affiliation
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cheng-Hsing Hsieh
City
Taipei
State/Province
Xindian
ZIP/Postal Code
23142
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jih-Rong Yang, MSc
Phone
+886-6628-9779
Ext
2240
Email
xdb05251@tzuchi.com.tw

12. IPD Sharing Statement

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Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation

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