History of Changes for Study: NCT03177746

The Safety of Dapoxetine/Tadalafil Combination Therapy

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Study Record Versions

Version	Submitted Date	Changes
1	June 5, 2017	None (earliest Version on record)
2	June 23, 2017	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	November 21, 2017	Recruitment Status, Study Status and Contacts/Locations
4	December 12, 2017	Contacts/Locations and Study Status
5	June 13, 2018	Study Status and Contacts/Locations
6	October 2, 2019	Recruitment Status, Contacts/Locations and Study Status
7	June 5, 2020	Study Status
8	December 9, 2021	Recruitment Status, Study Status and Contacts/Locations
9	May 16, 2022	Recruitment Status and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	NEU-10.16
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
Secondary IDs:

Study Status


Record Verification:	June 2017
Overall Status:	Not yet recruiting
Study Start:	July 3, 2017
Primary Completion:	November 3, 2017 [Anticipated]
Study Completion:	December 3, 2017 [Anticipated]

First Submitted:	May 23, 2017
First Submitted that Met QC Criteria:	June 5, 2017
First Posted:	June 6, 2017 [Actual]

Last Update Submitted that Met QC Criteria:	June 5, 2017
Last Update Posted:	June 6, 2017 [Actual]

Sponsor/Collaborators


Sponsor:	Neutec Ar-Ge San ve Tic A.Ş
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

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.
Detailed Description:

Conditions


Conditions:	Premature Ejaculation Erectile Dysfunction Safety Issues
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 4
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	40 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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

Outcome Measures


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.

Eligibility


Minimum Age:	18 Years
Maximum Age:	64 Years
Sex:	Male
Gender Based:	Yes
	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

Contacts/Locations


Central Contact Person:	Çağ Çal, Prof Dr Telephone: 00902324441343 Ext. 0000 Email: cag.cal@cagcal.com
Central Contact Backup:	Tuncer Bahçeci, Dr Telephone: 00902324441343 Ext. 0000 Email: tuncerbahceci@gmail.com
Locations:	Turkey, Bornova
	Ege University Faculty of Medicine İzmir, Bornova, Turkey, 35040 Contact:Contact: Çağ Çal, Prof Dr 00902324441343 Ext. 0000 cag.cal@cagcal.com Contact:Contact: Tuncer Bahçeci, Dr 00902324441343 Ext. 0000 tuncerbahceci@gmail.com Contact:Principal Investigator: Çağ Çal, Prof Dr Contact:Sub-Investigator: Tuncer Bahçeci, Dr

IPDSharing


Plan to Share IPD:	Undecided

References


Citations:
Links:
Available IPD/Information: