- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02939495
The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy (DAP-SPEED)
May 16, 2019 updated by: Neutec Ar-Ge San ve Tic A.Ş
The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy in the Treatment of Men With Premature Ejaculation and Erectile Dysfunction (DAP-SPEED Study)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
75
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34100
- Bagcilar Research and Training Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study drug
Dapoxetine/Sildenafil 30/50 mg film coated tablet
|
1 tablet before sexual intercourse
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline.
Time Frame: 4-weeks
|
4-weeks
|
The evaluation of IIEF-15 (International Index of Erectile Function Questionnaire) score compared to baseline.
Time Frame: 4-weeks
|
4-weeks
|
The evaluation of premature ejaculation symptom scores compared to baseline.
Time Frame: 4-weeks
|
4-weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The evaluation of Premature Ejaculation response measured by Premature Ejaculation Profile (PEP)
Time Frame: 4-weeks
|
4-weeks
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The Rate of Premature Ejaculation Profile (PEP) response
Time Frame: 4-weeks
|
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)
Time Frame: 4-weeks
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4-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ege Can Şerefoğlu, Assoc Prof Dr, Bahçeci Grup
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
August 20, 2016
First Submitted That Met QC Criteria
October 19, 2016
First Posted (Estimate)
October 20, 2016
Study Record Updates
Last Update Posted (Actual)
May 20, 2019
Last Update Submitted That Met QC Criteria
May 16, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pregnancy Complications
- Obstetric Labor Complications
- Sexual Dysfunctions, Psychological
- Obstetric Labor, Premature
- Sexual Dysfunction, Physiological
- Premature Birth
- Erectile Dysfunction
- Premature Ejaculation
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Sildenafil Citrate
Other Study ID Numbers
- NEU-16.12
- 16-NEU-1 (Other Identifier: Ministry of Health, Turkey)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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