Premature EjaculationPhase 4DAP-SPEEDNCT02939495
The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy
A Phase 4 study testing Dapoxetine/Sildenafil 30/50 mg film coated tablet in people with Premature Ejaculation and Erectile Dysfunction, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Premature Ejaculation, Erectile Dysfunction
- What is being tested?
- Dapoxetine/Sildenafil 30/50 mg film coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2016to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Research and Training Hospital
Istanbul, 34100
About this study
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)
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.
Read the 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.
- Conditions
- Premature Ejaculation, Erectile Dysfunction
- Being tested
- Dapoxetine/Sildenafil 30/50 mg film coated tablet
- Keywords
- Premature Ejaculation, Erectile Dysfunction, DAP-SPEED, Dapoxetine, Sildenafil
- Medical subject headings
- Premature Ejaculation, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapoxetine/Sildenafil 30/50 mg film coated tabletDrug
Also called Dapoxil
1 tablet before sexual intercourse
| Study group | Role | What they receive |
|---|---|---|
| Study drug | Experimental | Dapoxetine/Sildenafil 30/50 mg film coated tablet Receives: Drug: Dapoxetine/Sildenafil 30/50 mg film coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline.
Measured: 4-weeks
The evaluation of IIEF-15 (International Index of Erectile Function Questionnaire) score compared to baseline.
Measured: 4-weeks
The evaluation of premature ejaculation symptom scores compared to baseline.
Measured: 4-weeks
Secondary outcomes (3)
The evaluation of Premature Ejaculation response measured by Premature Ejaculation Profile (PEP)
Measured: 4-weeks
The Rate of Premature Ejaculation Profile (PEP) response
Measured: 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)
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ege Can Şerefoğlu, Assoc Prof Dr, Principal investigator, Bahçeci Grup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939495
- Sponsor's protocol ID
- NEU-16.12
- Other IDs
- 16-NEU-1
- Acronym
- DAP-SPEED
- Status last verified
- May 2019
- First submitted
- 20 Aug 2016
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30705437
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02939495
- Acronym / sponsor ID
- DAP-SPEED / NEU-16.12
- Conditions
- Premature Ejaculation, Erectile Dysfunction
- Keywords
- Premature Ejaculation, Erectile Dysfunction, DAP-SPEED, Dapoxetine, Sildenafil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study drug | Experimental | Drug: Dapoxetine/Sildenafil 30/50 mg film coated tabletDapoxetine/Sildenafil 30/50 mg film coated tablet |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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) ,
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapoxetine/Sildenafil 30/50 mg film coated tabletAlso: Dapoxil1 tablet before sexual intercourse | Drug | Study drug |
Primary outcome
The evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline.
Time frame: 4-weeks
The evaluation of IIEF-15 (International Index of Erectile Function Questionnaire) score compared to baseline.
Time frame: 4-weeks
The evaluation of premature ejaculation symptom scores compared to baseline.
Time frame: 4-weeks
3 secondary outcomes
The evaluation of Premature Ejaculation response measured by Premature Ejaculation Profile (PEP)
Time frame: 4-weeks
The Rate of Premature Ejaculation Profile (PEP) response
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Results publication: PubMed 30705437Tuken 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ege Can Şerefoğlu, Assoc Prof Dr principal investigator
Bahçeci Grup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapoxetine/Sildenafil 30/50 mg film coated tablet in people with Premature Ejaculation and Erectile Dysfunction, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline. (time frame: 4-weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.