The Safety of Dapoxetine/Tadalafil Combination Therapy

NCT03177746 | Unknown Phase 4

• 1 other identifier: NEU-10.16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ejaculation; Erectile Dysfunction; Safety Issues

Outcome Measures

Primary Outcomes (1)

• Evaluation of safety of study drug

  Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  4 weeks

Secondary Outcomes (3)

• Evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline

  4 weeks

• Evaluation of IIEF-15 (International Index of Erectile Function) score compared to baseline

  4 weeks

• Evaluation of premature ejaculation symptom scores compared to baseline

  4 weeks

Study Arms (1)

Dapoxetine/Tadalafil 30/20 mg film coated tablet

EXPERIMENTAL

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

Interventions

Dapoxetine/Tadalafil 30/20 mg film coated tablet DRUG

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.

Also known as: Tada Plus

Dapoxetine/Tadalafil 30/20 mg film coated tablet

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Since drug is indicated in men, study population will consist of men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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,

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

Study Sites (1)

Okmeydanı Training and Research Hospital Urology Dep.

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Ejaculation; Erectile Dysfunction

Interventions

dapoxetine; Tadalafil

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Neutec R&D

CONTACT

00902128505102

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 6, 2017
• Study Start: December 31, 2022
• Primary Completion: January 14, 2023
• Study Completion: October 14, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

TU (1)