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The Safety of Dapoxetine/Tadalafil Combination Therapy

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ClinicalTrials.gov Identifier: NCT03177746
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Neutec Ar-Ge San ve Tic A.Ş

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.

Condition or disease Intervention/treatment Phase
Premature Ejaculation Erectile Dysfunction Safety Issues Drug: Dapoxetine/Tadalafil 30/20 mg film coated tablet Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety of Dapoxetine/Tadalafil Combination Therapy in Treatment of Men With Premature Ejaculation and Erectile Dysfunction
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : November 14, 2018
Estimated Study Completion Date : March 14, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

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 Name: Tada Plus




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Evaluation of premature ejaculation symptom scores compared to baseline [ Time Frame: 4 weeks ]
    Increase in IIEF scores will be considered as efficacy.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Since drug is indicated in men, study population will consist of men.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177746


Contacts
Contact: Neutec R&D 00902128505102 ext 0000 iremkaraman@neutecrdc.com

Locations
Turkey
Ege University Medical Faculty Urology Dep. Recruiting
İzmir, Turkey, 35040
Contact: Çağ Çal, Prof Dr    00902324441343 ext 0000    cag.cal@cagcal.com   
Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş

Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
ClinicalTrials.gov Identifier: NCT03177746     History of Changes
Other Study ID Numbers: NEU-10.16
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Erectile Dysfunction
Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents