Back to resultsObservational Study of Pharmacological Treatment for Premature Ejaculation Concurrent With Erectile Dysfunction
Primary Purpose
Premature Ejaculation, Erectile Dysfunction
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dapoxetine
Tadalafil
Tadalafil
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation
Eligibility Criteria
Inclusion Criteria:
- PE concurrent with ED: the IELT is less than 3 minutes, the PEDT score is ≥11 points, and 5≤IIEF-5≤21 points.
- 18-60 years old, outpatient or physical examination population, with regular sex partners and regular sex life;
- Having the data below,and willing to participate in the trial（1）Demographic information: age, gender, nationality, birthplace, etc;(2) Physical examination data: height, weight, abdominal circumference, blood pressure, heart rate, etc ;(3) Medical history data: history of present illness, past medical history, family history, etc;(4) Scale evaluation: Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP), International Erectile Function Score-5(IIEF-5), Erectile Hardness Grading Score (EHGS), Clinical Global Impression of Change (GICC);
Exclusion Criteria:
- Age <18 years or> 60 years;
- There is a history of acute and chronic diseases, major trauma and surgery, etc;
- A long history of medication;
- There is a history of unstable myocardial infarction and cerebral infarction;
- A history of cardiogenic shock, severe heart failure, severe ventricular arrhythmia, etc;
- There are serious diseases such as malignant tumors, chronic liver and kidney diseases, etc.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
tadalafil combined with dapoxetine
tadalafil mono group
Arm Description
Outcomes
Primary Outcome Measures
The change of Premature Ejaculation Profile (PEP) at week 8
The PEP is a 4-question PRO that asks a respondent about his subjective sense of control over ejaculation, distress related to PE, interpersonal difficulty and satisfaction with sexual intercourse.
The change of International Index of Erectile Function -5(IIEF-5) at week 8
Secondary Outcome Measures
Incidence of adverse reactions
To observe the safety of the two regiments in PE concurrent with ED patients
The change of Erection Hardness Score (EHS)
Erection Hardness Score as a self-reporting measure that scored erection hardness on a 4 point scale. The aim was to help men, their partners and doctors diagnose erectile dysfunction.
Clinical Global Impression of Change (GICC)
Clinical Global Impression is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04361305
Brief Title
Observational Study of Pharmacological Treatment for Premature Ejaculation Concurrent With Erectile Dysfunction
Official Title
Multicenter Study of the Efficacy and Safety of Dapoxetine Combined With Tadalafil in Men With Premature Ejaculation and Concomitant Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 3, 2020 (Anticipated)
Primary Completion Date
January 11, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yan-Ping Huang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Premature ejaculation (PE) is a common disease in the andrology clinic. Currently, the effectiveness and outcome differences of drug treatment still need to be studied and demonstrated. Premature ejaculation concurrent with erectile dysfunction (ED) is common in outpatient clinics. The preferred treatment plan for these patients still needs to be further studied and explored, and the difference in the efficacy of different treatment regiments remain to be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation, Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tadalafil combined with dapoxetine
Arm Type
Experimental
Arm Title
tadalafil mono group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dapoxetine
Intervention Description
30 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 8 weeks Tadalafil 5 mg tablets every day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Intervention Description
5 mg tablets every day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Intervention Description
5 mg tablets every day for 8 weeks
Primary Outcome Measure Information:
Title
The change of Premature Ejaculation Profile (PEP) at week 8
Description
The PEP is a 4-question PRO that asks a respondent about his subjective sense of control over ejaculation, distress related to PE, interpersonal difficulty and satisfaction with sexual intercourse.
Time Frame
Baseline, Week 8
Title
The change of International Index of Erectile Function -5(IIEF-5) at week 8
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Incidence of adverse reactions
Description
To observe the safety of the two regiments in PE concurrent with ED patients
Time Frame
Baseline, Week 8
Title
The change of Erection Hardness Score (EHS)
Description
Erection Hardness Score as a self-reporting measure that scored erection hardness on a 4 point scale. The aim was to help men, their partners and doctors diagnose erectile dysfunction.
Time Frame
Baseline, Week 8
Title
Clinical Global Impression of Change (GICC)
Description
Clinical Global Impression is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Time Frame
Baseline, Week 8
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PE concurrent with ED: the IELT is less than 3 minutes, the PEDT score is ≥11 points, and 5≤IIEF-5≤21 points.
18-60 years old, outpatient or physical examination population, with regular sex partners and regular sex life;
Having the data below,and willing to participate in the trial（1）Demographic information: age, gender, nationality, birthplace, etc;(2) Physical examination data: height, weight, abdominal circumference, blood pressure, heart rate, etc ;(3) Medical history data: history of present illness, past medical history, family history, etc;(4) Scale evaluation: Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP), International Erectile Function Score-5(IIEF-5), Erectile Hardness Grading Score (EHGS), Clinical Global Impression of Change (GICC);
Exclusion Criteria:
Age <18 years or> 60 years;
There is a history of acute and chronic diseases, major trauma and surgery, etc;
A long history of medication;
There is a history of unstable myocardial infarction and cerebral infarction;
A history of cardiogenic shock, severe heart failure, severe ventricular arrhythmia, etc;
There are serious diseases such as malignant tumors, chronic liver and kidney diseases, etc.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Observational Study of Pharmacological Treatment for Premature Ejaculation Concurrent With Erectile Dysfunction
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