Premature Ejaculation Clinical Trial
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).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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: - a1-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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Cheng-Hsing Hsieh | Taipei | Xindian |
Lead Sponsor | Collaborator |
---|---|
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intravaginal Ejaculatory Latency Time (IELT) | up to 12 weeks | No | |
Secondary | Erectile function domain of the International Index of Erectile Function (IIEF) | Baseline | Yes | |
Secondary | Premature Ejaculation Diagnostic Tool (PEDT) | Baseline | No | |
Secondary | Index of Premature Ejaculation (IPE) | up to 12 weeks | No | |
Secondary | Premature Ejaculation Profile (PEP) | up to 12 weeks | No | |
Secondary | Clinical Global Impression of Change (CGIC) | up to 12 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02232425 -
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
|
Phase 2 | |
Completed |
NCT01439984 -
Trial of PED-1 in Male Patients With Premature Ejaculation
|
Phase 3 | |
Completed |
NCT01203202 -
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
|
Phase 2 | |
Completed |
NCT01184105 -
A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation
|
Phase 1 | |
Completed |
NCT03942367 -
Evaluation of the Safety and Effectiveness of the vPatch Device
|
N/A | |
Recruiting |
NCT06425211 -
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
|
N/A | |
Completed |
NCT02939495 -
The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy
|
Phase 4 | |
Completed |
NCT02572037 -
Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research
|
||
Terminated |
NCT00983736 -
Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation
|
Phase 3 | |
Completed |
NCT00549211 -
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
|
Phase 1 | |
Completed |
NCT00556478 -
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05556083 -
Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)
|
Phase 2 | |
Completed |
NCT03304808 -
Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0
|
N/A | |
Completed |
NCT00861484 -
Proof of Mechanism in ELT
|
Phase 1 | |
Completed |
NCT02984592 -
Effect of Exercise on Premature Ejaculation
|
N/A | |
Recruiting |
NCT02571101 -
A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation
|
Phase 2 | |
Completed |
NCT03174470 -
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
|
N/A | |
Completed |
NCT02794454 -
A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health
|
N/A | |
Completed |
NCT02297152 -
A New Treatment for Premature Ejaculation?
|
N/A | |
Not yet recruiting |
NCT00656552 -
Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation
|
Phase 0 |