Premature EjaculationPhase 4NCT03177746
The Safety of Dapoxetine/Tadalafil Combination Therapy
A Phase 4 study testing Dapoxetine/Tadalafil 30/20 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 safety and efficacy of Dapoxetine/Tadalafil 30/20 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, Safety Issues
- What is being tested?
- Dapoxetine/Tadalafil 30/20 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
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2022to 14 Oct 2023
- 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 erectile dysfunction or premature ejaculation 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), atrioventricular block or message disorder such as sick sinus syndrome, severe ischemic cardiac disease, syncope, unstable angina, 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 <90/50 mmHg and 170/100 mmHg<
- History of allergy to Selective Serotonin Reuptake Inhibitor (SSRI) and phosphodiesterase inhibitor drugs,
- Continuing to use or quitted in last 3 months of Monoamine oxidase inhibitor (MAOI), Thioridazine, Serotonin Reuptake Inhibitor (SSRI), Selective-norepinephrine 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, erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem, any kind of vasodilator, antiplatelet, anticoagulant, dapoxetine, phosphodiesterase 5 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.
Neutec R&D contact
Turkey (Türkiye)1 site
Okmeydanı Training and Research Hospital Urology Dep.
Istanbul
Mehmet Gokhan Culha, Dr, 00902123145555 ext. 0000, gokhan_culha64@hotmail.com
About this study
Official title: The Safety of Dapoxetine/Tadalafil Combination Therapy in Treatment of Men With Premature Ejaculation and Erectile Dysfunction
The purpose of this study is to evaluate the safety and efficacy of Dapoxetine/Tadalafil 30/20 mg film-coated tablet in the treatment of men with premature ejaculation and erectile dysfunction.
- Conditions
- Premature Ejaculation, Erectile Dysfunction, Safety Issues
- Being tested
- Dapoxetine/Tadalafil 30/20 mg film coated tablet
- 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/Tadalafil 30/20 mg film coated tabletDrug
Also called Tada Plus
During 4-weeks treatment period, patients will take one Dapoxetine/Tadalafil 30/20 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 group | Role | What they receive |
|---|---|---|
| Dapoxetine/Tadalafil 30/20 mg film coated tablet | Experimental | Not described Receives: Drug: Dapoxetine/Tadalafil 30/20 mg film coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (3)
Evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline
Intra-vaginal ejaculation latency time difference of one minute or more will be considered as efficient.
Measured: 4 weeks
Evaluation of IIEF-15 (International Index of Erectile Function) score compared to baseline
Increase in IIEF score will be considered as efficacy.
Measured: 4 weeks
Evaluation of premature ejaculation symptom scores compared to baseline
Increase in IIEF scores will be considered as efficacy.
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 posted6 Jun 2017
- Study start31 Dec 2022 (estimated)
- Primary completion14 Jan 2023 (estimated)
- Study completion14 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177746
- Sponsor's protocol ID
- NEU-10.16
- Status last verified
- May 2022
- First submitted
- 23 May 2017
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Dapoxetine/Tadalafil Combination Therapy in Treatment of Men With Premature Ejaculation and Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT03177746
- Acronym / sponsor ID
- NEU-10.16
- Conditions
- Premature Ejaculation, Erectile Dysfunction, Safety Issues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2022 (estimated)
- Primary completion
- 14 Jan 2023 (estimated)
- Study completion
- 14 Oct 2023 (estimated)
- First posted
- 6 Jun 2017 (actual)
- 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 safety and efficacy of Dapoxetine/Tadalafil 30/20 mg film-coated tablet in the treatment of men with premature ejaculation and erectile dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dapoxetine/Tadalafil 30/20 mg film coated tablet | Experimental | Drug: Dapoxetine/Tadalafil 30/20 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 erectile dysfunction or premature ejaculation 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/Tadalafil 30/20 mg film coated tabletAlso: Tada PlusDuring 4-weeks treatment period, patients will take one Dapoxetine/Tadalafil 30/20 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. | Drug | Dapoxetine/Tadalafil 30/20 mg film coated tablet |
Primary outcome
Evaluation of safety of study drug
Time frame: 4 weeks
Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
3 secondary outcomes
Evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline
Time frame: 4 weeks
Evaluation of IIEF-15 (International Index of Erectile Function) score compared to baseline
Time frame: 4 weeks
Evaluation of premature ejaculation symptom scores compared to baseline
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- 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.
Neutec R&D contact
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/Tadalafil 30/20 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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neutec R&D (00902128505102 ext. 0000), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of safety of study drug (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2022.