Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT04361305
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04361305
Study Brief:
Protocol Section:
NCT04361305