The Safety of Dapoxetine/Tadalafil Combination Therapy

May 16, 2022 updated by: Neutec Ar-Ge San ve Tic A.Ş

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Neutec R&D
  • Phone Number: 0000 00902128505102

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Okmeydanı Training and Research Hospital Urology Dep.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks
Evaluation of premature ejaculation symptom scores compared to baseline
Time Frame: 4 weeks
Increase in IIEF scores will be considered as efficacy.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neutec Ar-Ge San ve Tic A.Ş

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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