The Safety of Dapoxetine/Tadalafil Combination Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction; Premature Ejaculation; Safety Issues
• Intervention / Treatment: Drug: Dapoxetine/Tadalafil 30/20 mg film coated tablet

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Neutec R&D; Phone Number: 0000 00902128505102

Study Locations

• Turkey
  • Istanbul, Turkey
    • Okmeydanı Training and Research Hospital Urology Dep.
    • Contact: Mehmet Gokhan Culha, Dr; Phone Number: 0000 00902123145555; Email: gokhan_culha64@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapoxetine/Tadalafil 30/20 mg film coated tablet	Drug: Dapoxetine/Tadalafil 30/20 mg film coated tablet; 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.; Other Names: Tada Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
Evaluation of IIEF-15 (International Index of Erectile Function) score compared to baseline	Increase in IIEF score will be considered as efficacy.	4 weeks
Evaluation of premature ejaculation symptom scores compared to baseline	Increase in IIEF scores will be considered as efficacy.	4 weeks

Collaborators and Investigators

• Sponsor: Neutec Ar-Ge San ve Tic A.Ş

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2022
• Primary Completion (Anticipated): January 14, 2023
• Study Completion (Anticipated): October 14, 2023

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Erectile Dysfunction; Premature Ejaculation; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: NEU-10.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No