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The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy (DAP-SPEED)

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ClinicalTrials.gov Identifier: NCT02939495
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Neutec Ar-Ge San ve Tic A.Ş

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.

Condition or disease Intervention/treatment Phase
Premature Ejaculation Erectile Dysfunction Drug: Dapoxetine/Sildenafil 30/50 mg film coated tablet Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy in the Treatment of Men With Premature Ejaculation and Erectile Dysfunction (DAP-SPEED Study)
Actual Study Start Date : October 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study drug
Dapoxetine/Sildenafil 30/50 mg film coated tablet
Drug: Dapoxetine/Sildenafil 30/50 mg film coated tablet
1 tablet before sexual intercourse
Other Name: Dapoxil




Primary Outcome Measures :
  1. The evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline. [ Time Frame: 4-weeks ]
  2. The evaluation of IIEF-15 (International Index of Erectile Function Questionnaire) score compared to baseline. [ Time Frame: 4-weeks ]
  3. The evaluation of premature ejaculation symptom scores compared to baseline. [ Time Frame: 4-weeks ]

Secondary Outcome Measures :
  1. The evaluation of Premature Ejaculation response measured by Premature Ejaculation Profile (PEP) [ Time Frame: 4-weeks ]
  2. The Rate of Premature Ejaculation Profile (PEP) response [ Time Frame: 4-weeks ]
  3. The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment) [ Time Frame: 4-weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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,
  • 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,
  • Patients on a different therapy (behavioral therapy or other drugs that are applied locally) for PE treatment
  • During the study, the possibility of taking medication which may affect the study drug's pharmacokinetic/pharmacodynamic properties
  • Patients who are defining symptoms of prostatitis clinically
  • Thyroid hormone disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939495


Locations
Turkey
Bagcilar Research and Training Hospital
Istanbul, Turkey, 34100
Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş
Investigators
Principal Investigator: Ege Can Şerefoğlu, Assoc Prof Dr Bahçeci Grup

Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
ClinicalTrials.gov Identifier: NCT02939495     History of Changes
Other Study ID Numbers: NEU-16.12
16-NEU-1 ( Other Identifier: Ministry of Health, Turkey )
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Neutec Ar-Ge San ve Tic A.Ş:
Premature Ejaculation
Erectile Dysfunction
DAP-SPEED
Dapoxetine
Sildenafil

Additional relevant MeSH terms:
Premature Birth
Erectile Dysfunction
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents