The Safety of Dapoxetine/Tadalafil Combination Therapy

Neutec Ar-Ge San ve Tic

Status and phase: Unknown; Phase 4

Conditions: Erectile Dysfunction; Safety Issues; Premature Ejaculation

Treatments: Drug: Dapoxetine/Tadalafil 30/20 mg film coated tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03177746

NEU-10.16

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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 <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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Dapoxetine/Tadalafil 30/20 mg film coated tablet

Experimental group

Treatment:

Drug: Dapoxetine/Tadalafil 30/20 mg film coated tablet