The Safety of Dapoxetine/Tadalafil Combination Therapy
Primary Purpose
Premature Ejaculation, Erectile Dysfunction, Safety Issues
Status
Not yet recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dapoxetine/Tadalafil 30/20 mg film coated tablet
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation
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
Sites / Locations
- Okmeydanı Training and Research Hospital Urology Dep.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dapoxetine/Tadalafil 30/20 mg film coated tablet
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of safety of study drug
Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Secondary Outcome Measures
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.
Evaluation of IIEF-15 (International Index of Erectile Function) score compared to baseline
Increase in IIEF score will be considered as efficacy.
Evaluation of premature ejaculation symptom scores compared to baseline
Increase in IIEF scores will be considered as efficacy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03177746
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2022 (Anticipated)
Primary Completion Date
January 14, 2023 (Anticipated)
Study Completion Date
October 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neutec Ar-Ge San ve Tic A.Ş
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation, Erectile Dysfunction, Safety Issues
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dapoxetine/Tadalafil 30/20 mg film coated tablet
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dapoxetine/Tadalafil 30/20 mg film coated tablet
Other Intervention Name(s)
Tada Plus
Intervention Description
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 Outcome Measure Information:
Title
Evaluation of safety of study drug
Description
Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline
Description
Intra-vaginal ejaculation latency time difference of one minute or more will be considered as efficient.
Time Frame
4 weeks
Title
Evaluation of IIEF-15 (International Index of Erectile Function) score compared to baseline
Description
Increase in IIEF score will be considered as efficacy.
Time Frame
4 weeks
Title
Evaluation of premature ejaculation symptom scores compared to baseline
Description
Increase in IIEF scores will be considered as efficacy.
Time Frame
4 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Since drug is indicated in men, study population will consist of men.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neutec R&D
Phone
00902128505102
Ext
0000
Facility Information:
Facility Name
Okmeydanı Training and Research Hospital Urology Dep.
City
Istanbul
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Gokhan Culha, Dr
Phone
00902123145555
Ext
0000
Email
gokhan_culha64@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Safety of Dapoxetine/Tadalafil Combination Therapy
We'll reach out to this number within 24 hrs