Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation

NCT02581826 | Unknown Phase 2

• 1 other identifier: 01-X15-058
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• Intravaginal Ejaculatory Latency Time (IELT)

  up to 12 weeks

Secondary Outcomes (5)

• Erectile function domain of the International Index of Erectile Function (IIEF)

  Baseline

• Premature Ejaculation Diagnostic Tool (PEDT)

  Baseline

• Index of Premature Ejaculation (IPE)

  up to 12 weeks

• Premature Ejaculation Profile (PEP)

  up to 12 weeks

• Clinical Global Impression of Change (CGIC)

  up to 12 weeks

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Silodosin DRUG

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.

Also known as: Urief

Silodosin

Placebo DRUG

No column specified.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Cheng-Hsing Hsieh

Taipei, Xindian, 23142, Taiwan

RECRUITING

MeSH Terms

Conditions

Premature Ejaculation

Interventions

silodosin

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Cheng-Hsing Hsieh, MD

  Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Hsing Hsieh, MD

CONTACT

+886-6628-9779; kevinchhsieh@tzuchi.com.tw

Jih-Rong Yang, MSc

CONTACT

+886-6628-9779; xdb05251@tzuchi.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cheng-Hsing Hsieh

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

TW (1)