The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy

NCT02939495 | Completed Phase 4

• 2 other identifiers: NEU-16.1216-NEU-1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Ejaculation; Erectile Dysfunction

Keywords

Premature Ejaculation; Erectile Dysfunction; DAP-SPEED; Dapoxetine; Sildenafil

Outcome Measures

Primary Outcomes (3)

• The evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline.

  4-weeks

• The evaluation of IIEF-15 (International Index of Erectile Function Questionnaire) score compared to baseline.

  4-weeks

• The evaluation of premature ejaculation symptom scores compared to baseline.

  4-weeks

Secondary Outcomes (3)

• The evaluation of Premature Ejaculation response measured by Premature Ejaculation Profile (PEP)

  4-weeks

• The Rate of Premature Ejaculation Profile (PEP) response

  4-weeks

• The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment)

  4-weeks

Study Arms (1)

Study drug

EXPERIMENTAL

Dapoxetine/Sildenafil 30/50 mg film coated tablet

Drug: Dapoxetine/Sildenafil 30/50 mg film coated tablet

Interventions

Dapoxetine/Sildenafil 30/50 mg film coated tablet DRUG

1 tablet before sexual intercourse

Also known as: Dapoxil

Study drug

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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,
• Patients who are not eligible to have sexual intercourse due to existing health problems,
• Autonomic neuropathy, retinitis pigmentosa, blood diseases, active peptic ulcer, abnormalities in ECG, severe systemic disease that cannot be controlled,
• Systolic/Diastolic blood pressure at rest \<90/50mmHg and 170/100mmHg\<
• History of allergy to Selective Serotonine Reuptake Inhibitor (SSRI) and phosphodiesterase inhibitor drugs,
• Continuing to use or quitted in last 3 months of Monoamine oxidase inhibitor (MAOI), Thioridazine, Serotonine Reuptake Inhibitor (SSRI), Selective-Norepinephrin Reuptake Inhibitor (SNRI), Serotonergic drug/herbal product, tricyclic antidepressant and atypical antipsychotic drugs,
• Use of nitrates, alfa blockers, vasodilators, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, cimetidine, erithromicin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem, any kind of vasodilator, antiplatelet, anticoagulant, dapoxetine, PDE5 inhibitor, alcohol and stimulant drug,

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

Study Sites (1)

Bagcilar Research and Training Hospital

Istanbul, 34100, Turkey (Türkiye)

Location

Related Publications (1)

• Tuken M, Culha MG, Serefoglu EC. Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction-DAP-SPEED Study. Int J Impot Res. 2019 Mar;31(2):92-96. doi: 10.1038/s41443-019-0122-2. Epub 2019 Jan 31.

  PMID: 30705437 RESULT

MeSH Terms

Conditions

Premature Ejaculation; Erectile Dysfunction

Interventions

dapoxetine; Sildenafil Citrate

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)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ege Can Şerefoğlu, Assoc Prof Dr

  Bahçeci Grup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2016
• First Posted: October 20, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

TU (1)