The Safety of Dapoxetine/Tadalafil Combination Therapy

• ClinicalTrials.gov Identifier: NCT03177746
• Recruitment Status: Unknown
• First Posted: June 6, 2017
• Last Update Posted: May 17, 2022
• Sponsor: Neutec Ar-Ge San ve Tic A.Ş
• Information provided by (Responsible Party): Neutec Ar-Ge San ve Tic A.Ş

Tracking Information

• First Submitted Date: May 23, 2017
• First Posted Date: June 6, 2017
• Last Update Posted Date: May 17, 2022
• Estimated Study Start Date: December 31, 2022
• Estimated Primary Completion Date: January 14, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2017)

Evaluation of safety of study drug [ Time Frame: 4 weeks ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 5, 2017)

• Evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline [ Time Frame: 4 weeks ]
  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 [ Time Frame: 4 weeks ]
  Increase in IIEF score will be considered as efficacy.
• Evaluation of premature ejaculation symptom scores compared to baseline [ Time Frame: 4 weeks ]
  Increase in IIEF scores will be considered as efficacy.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Premature Ejaculation
• Erectile Dysfunction
• Safety Issues

Intervention

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 Name: Tada Plus

Study Arms

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

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 5, 2017): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 14, 2023
• Estimated Primary Completion Date: January 14, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Since drug is indicated in men, study population will consist of men.

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT03177746
• Other Study ID Numbers: NEU-10.16
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
• Original Responsible Party: Same as current
• Current Study Sponsor: Neutec Ar-Ge San ve Tic A.Ş
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Neutec Ar-Ge San ve Tic A.Ş
• Verification Date: May 2022