The Safety of Dapoxetine/Tadalafil Combination Therapy
Overview
This trial is active, not recruiting.
| Conditions | premature ejaculation, erectile dysfunction, safety issues |
| Treatment | dapoxetine/tadalafil 30/20 mg film coated tablet |
| Phase | phase 4 |
| Sponsor | Neutec Ar-Ge San ve Tic A.Ş |
| Start date | September 2017 |
| End date | January 2020 |
| Trial size | 40 participants |
| Trial identifier | NCT03177746, NEU-10.16 |
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.
| United States | No locations recruiting |
| Other countries | Turkey |
Study Design
| Intervention model | single group assignment |
| Primary purpose | treatment |
| Masking | none (open label) |
| Arm |
|---|
| dapoxetine/tadalafil 30/20 mg film coated tablet 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. |
Primary Outcomes
Secondary Outcomes
Eligibility Criteria
Male participants from 18 years up to 64 years old.
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 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, – 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
Additional Information
| Official title | The Safety of Dapoxetine/Tadalafil Combination Therapy in Treatment of Men With Premature Ejaculation and Erectile Dysfunction |
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