Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride

NCT03879746 | Unknown Phase 3

• 1 other identifier: premature ejaculation
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to compare the effect of tamsulosin versus the effect of paroxetine hydrochloride and the effect of combination of them on PE.

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• Premature Ejaculation Diagnostic Tool

  Patients will be asked to complete the PEDT ( Premature Ejaculation Diagnostic Tool ) Cases will be scored as follow : * Score of less than or equal 8 indicate no PE . * Score of 9 and 10 indicate probable PE . * Score of more than or equal 11 indicate PE After about 12 weeks the patients will be reevaluated also by ( PEDT ) and the results will be compared with the pretreatment ones

  3 months

Secondary Outcomes (1)

• Intravaginal Ejaculatory Latency Time

  3 months

Study Arms (4)

tamsulosin group

ACTIVE COMPARATOR

the first group will include 40 patients treated with daily administration of tamsulosin 0.4 mg

Drug: Tamsulosin

paroxetine group

ACTIVE COMPARATOR

the second group will include 40 patients treated with daily administration of paroxetine 20 mg

Drug: Paroxetine Hydrochloride

combined group

ACTIVE COMPARATOR

the third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg

Drug: Tamsulosin; Drug: Paroxetine Hydrochloride

placrbo group

PLACEBO COMPARATOR

the fourth group will include 40 patients will be given placebo

Other: placebo

Interventions

Tamsulosin DRUG

drug will be used in treatment of premature ejaculation

combined group; tamsulosin group

Paroxetine Hydrochloride DRUG

drug will be used in treatment of premature ejaculation

combined group; paroxetine group

placebo OTHER

tablets without active substance will be given to patients suffering from premature ejaculation

placrbo group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Married, sexually active patients with PE will be included with ages ranging from 20 to 60 years.

You may not qualify if:

• Patients suffering from erectile dysfunction, DM, HTN, neurological disorders and psychological disorders.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Tamsulosin; Paroxetine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Asmaa Farrag

CONTACT

201128359948; asmaafarrag14@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 19, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03