Premature EjaculationPhase 2NCT02581826
Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation
A Phase 2 study testing Silodosin in people with Premature Ejaculation, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Silodosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cheng-Hsing Hsieh
Taipei, Xindian, 23142
Jih-Rong Yang, MSc, +886-6628-9779 ext. 2240, xdb05251@tzuchi.com.tw
About this study
Official title: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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).
Read the 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).
- Conditions
- Premature Ejaculation
- Being tested
- Silodosin, Placebo
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Also called Urief
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.
PlaceboDrug
No column specified.
| Study group | Role | What they receive |
|---|---|---|
| Silodosin | Active comparator | 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. Receives: Drug: Silodosin |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravaginal Ejaculatory Latency Time (IELT)
Measured: up to 12 weeks
Secondary outcomes (5)
Erectile function domain of the International Index of Erectile Function (IIEF)
Measured: Baseline
Premature Ejaculation Diagnostic Tool (PEDT)
Measured: Baseline
Index of Premature Ejaculation (IPE)
Measured: up to 12 weeks
Premature Ejaculation Profile (PEP)
Measured: up to 12 weeks
Clinical Global Impression of Change (CGIC)
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Hsing Hsieh, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Cheng-Hsing Hsieh, MD, Principal investigator, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581826
- Sponsor's protocol ID
- 01-X15-058
- Status last verified
- Jan 2016
- First submitted
- 15 Oct 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- ClinicalTrials.gov ID
- NCT02581826
- Acronym / sponsor ID
- 01-X15-058
- Conditions
- Premature Ejaculation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silodosin | Active comparator | Drug: Silodosin1. 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. |
| Placebo | Placebo comparator | Drug: Placebo1. 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilodosinAlso: Uriefα1-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. | Drug | Silodosin |
| PlaceboNo column specified. | Drug | Placebo |
Primary outcome
Intravaginal Ejaculatory Latency Time (IELT)
Time frame: up to 12 weeks
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Hsing Hsieh, MD principal investigator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Silodosin in people with Premature Ejaculation, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Hsing Hsieh, MD (+886-6628-9779 ext. 2240, kevinchhsieh@tzuchi.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravaginal Ejaculatory Latency Time (IELT) (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.