Clinical trial NCT03177746: The Safety of Dapoxetine/Tadalafil Combination Therapy
Official title: The Safety of Dapoxetine/Tadalafil Combination Therapy in Treatment of Men With Premature Ejaculation and Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Premature Ejaculation
Erectile Dysfunction
Safety Issues
Lead sponsor: Neutec Ar-Ge San ve Tic A.Ş
Sponsor class: INDUSTRY
First posted: 2017-06-06
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of safety of study drug
timeFrame: 4 weeks
Secondary outcomes:
measure: Evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline
timeFrame: 4 weeks
measure: Evaluation of IIEF-15 (International Index of Erectile Function) score compared to baseline
timeFrame: 4 weeks
measure: Evaluation of premature ejaculation symptom scores compared to baseline
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Okmeydanı Training and Research Hospital Urology Dep.
Study officials:
References: