The Safety of Dapoxetine/Tadalafil Combination Therapy
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03177746 |
Recruitment Status :
Not yet recruiting
First Posted : June 6, 2017
Last Update Posted : May 17, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | N/A |
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 |
Estimated Study Start Date : | December 31, 2022 |
Estimated Primary Completion Date : | January 14, 2023 |
Estimated Study Completion Date : | October 14, 2023 |
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 |
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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
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
Contact: Neutec R&D | 00902128505102 ext 0000 |
Turkey | |
Okmeydanı Training and Research Hospital Urology Dep. | |
Istanbul, Turkey | |
Contact: Mehmet Gokhan Culha, Dr 00902123145555 ext 0000 gokhan_culha64@hotmail.com |
Responsible Party: | Neutec Ar-Ge San ve Tic A.Ş |
ClinicalTrials.gov Identifier: | NCT03177746 |
Other Study ID Numbers: |
NEU-10.16 |
First Posted: | June 6, 2017 Key Record Dates |
Last Update Posted: | May 17, 2022 |
Last Verified: | May 2022 |
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 |
Premature Birth Erectile Dysfunction Premature Ejaculation Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases, Male Genital Diseases Sexual Dysfunction, Physiological |
Male Urogenital Diseases Sexual Dysfunctions, Psychological Mental Disorders Ejaculatory Dysfunction Tadalafil Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |