Erectile Dysfunction, Premature Ejaculation
Conditions
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.
Interventions
DRUGDapoxetine
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
DRUGTadalafil
5 mg tablets every day for 8 weeks
Sponsors
Yan-Ping Huang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. PE concurrent with ED: the IELT is less than 3 minutes, the PEDT score is ≥11 points, and 5≤IIEF-5≤21 points. 2. 18-60 years old, outpatient or physical examination population, with regular sex partners and regular sex life; 3. 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
1. Age \<18 years or\> 60 years; 2. There is a history of acute and chronic diseases, major trauma and surgery, etc; 3. A long history of medication; 4. There is a history of unstable myocardial infarction and cerebral infarction; 5. A history of cardiogenic shock, severe heart failure, severe ventricular arrhythmia, etc; 6. There are serious diseases such as malignant tumors, chronic liver and kidney diseases, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of Premature Ejaculation Profile (PEP) at week 8 | Baseline, 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 | Baseline, Week 8 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reactions | Baseline, Week 8 | To observe the safety of the two regiments in PE concurrent with ED patients |
| The change of Erection Hardness Score (EHS) | Baseline, Week 8 | 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) | Baseline, Week 8 | 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. |
Outcome results
None listed