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:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT01249703
Eligibility Criteria:
Inclusion Criteria:
1. Male and at least 18 years of age.
2. Provide signed informed consent.
3. Have a history of erectile dysfunction (ED: defined as a consistent change in the quality of erection that adversely affects the subject's satisfaction with sexual intercourse) .
4. Have a stable monogamous relationship with a female partner. To some subjects with poor sexual experience, re-evaluation would be conducted after a 4-weeks sex education.
5. Make at least four sexual intercourse attempts with the female sexual study partner during the 4-week therapeutic period without medication.
6. Agree not to use any other ED treatment for at least 4 weeks.
Exclusion Criteria:
1. severe diseases (such as congestive heart failure, arrhythmia, significant renal or hepatic dysfunction and anemia);
2. Had clinically noteworthy penile deformities, pelvic surgery or trauma of perineal region;
3. Had received long-term pharmacotherapy (including antioxidant agents, vitamins and traditional Chinese drugs).
4. An addiction problem (with a history of injection or administration of opium, poppy, heroin, hemp, morphine, cocaine, caffeine, ketamine and meperidine etc.)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01249703
Study Brief:
Protocol Section:
NCT01249703