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COMPLETEDPHASE4

The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy

The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy in the Treatment of Men With Premature Ejaculation and Erectile Dysfunction (DAP-SPEED Study)

NCT02939495•Neutec Ar-Ge San ve Tic A.Ş

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of Dapoxetine/Sildenafil 30/50 mg film-coated tablet in the treatment of men with premature ejaculation and erectile dysfunction.

Detailed Description

During 4-weeks treatment period, patients will take one Dapoxetine/Sildenafil 30/50 mg film coated tablet 1-3 hours before sexual intercourse. Study drug should not be used more than 1 tablet every 24 hours during the treatment.

Eligibility

Age

18 - 64 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•18-64 years old men,
•Participants must be heterosexual males and in a stable monogamous sexual relationship with a female partner for at least 6 months and will continue throughout the study,
•Clinical diagnosis of erectile dysfunction, IIEF score ≤21,
•Premature Ejaculation Diagnostic Tool (PEDT) score must be ≥11
•Patients with life-long PE and acquired PE according to the description of International Society for Sexual Medicine (ISSM) ,
•The patient and his partner must have sexual intercourse twice a week for the duration of the study,
•Commitment to comply with the study protocol,
•Patients who sign informed consent form (ICF).

Exclusion Criteria

•History of medical events such as surgical interventions or neurologic conditions (e.g., multiple sclerosis), trauma, or infections that are associated with the development of symptoms of premature ejaculation (PE) and considered a potential cause of PE,
•Having genital abnormalities, except penile curvature unless not prevent sexual intercourse,
•Developed ED or PE due to drug use or quit taking drugs,
•Any conditions that prevent sexual intercourse with partners
•History of epilepsy,
•Severe renal insufficiency,
•Liver disease,
•History of in last 6 months stroke, myocard infarction, cardiac insufficiency (New York Cardiovascular Associates (NYCA) phase II-IV), AV block or message disorder such as sick sinus syndrome, severe ischemic cardiac disease, syncope, unstable angına, life-threatening arrhythmia or hypotension,
•Non-Arteritic Anterior ischemic optic neuropathy,
•Autonomic neuropathy, retinitis pigmentosa, blood diseases, active peptic ulcer, abnormalities in ECG, severe systemic disease that cannot be controlled,
+8 more criteria

Locations (1)

Bagcilar Research and Training Hospital

Istanbul, Turkey (Türkiye)

Key Dates

Start Date

October 1, 2016

Primary Completion Date

June 1, 2017

Completion Date

August 1, 2017

Last Updated

May 20, 2019

Enrollment

ACTUAL participants

Conditions

Premature EjaculationErectile Dysfunction

Interventions

Dapoxetine/Sildenafil 30/50 mg film coated tablet

DRUG

Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction

NCT07480161

Erectile Dysfunction With Diabetes Mellitus

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RECRUITINGPHASE2

TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men

NCT07460960

Erectile Dysfunction Due to Arterial DiseaseAtheroscleroses+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy

Inclusion Criteria

Exclusion Criteria

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TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men

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