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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT05787769
Eligibility Criteria:
Inclusion Criteria:
* 1\) Signed an ethics committee-reviewed and approved informed consent form. 2) Subjects must meet all inclusion criteria to be eligible for study enrollment.
3\) Men between 30 and 75 years old, 4) Sexually active in a stable, heterosexual relationship of at least six months duration.
5\) ED for at least 6 months with an IIEF-EF between 5 and 16 points, inclusive. 6) ED of vascular origin. 7) Subjects agree to attempt vaginal intercourse at least 4 times every month after the end of the treatment and agree to document the outcome using the Sexual Encounter Profile (SEP) and the Erection Hardness Score (EHS).
8\) Commitment not to use other treatment for ED during the study (herbal, topical, intraurethral, intracavernosal, etc.).
9\) Willingness and ability to comply with study procedures, other measurements instruments and visit schedules and able to follow oral and written instructions.
Exclusion Criteria:
* 1\) Refuse to complete study requirements. 2) Psychogenic ED as determined by study investigator. 3) ED of neurogenic origin (radical cystectomy, radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, DM is not included unless documented diabetic neuropathy).
4\) Previous penile surgery of any kind (except circumcision, frenuloplasty and condyloma removal), such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication, grafting.
5\) Previous history of penile fracture, Peyronie's disease or priapism. 6) Previous radiation to pelvis. 7) History of symptomatic hypogonadism (testosterone level \<346ng/dl) not treated.
8\) Major hematologic, renal, or hepatic abnormalities. 9) Severe decompensated cardiac, CNS or vascular insufficiency. 10) Poorly controlled hypertension or DM (HbA1c \>12%). 11) Neoplasm of any origin in active treatment or active progression or recovering from cancer within 12 months prior to enrollment.
12\) History of alcohol abuse or drug. 13) Treatment with oral anticoagulants, antiandrogens or nitrates. 14) Thrombopenia less than 100 x 103 / L. 15) Hemoglobin \<10g/dl. 16) Poor venous access or any other circumstance that preclude an apheresis procedure.
17\) Sexually inactive in recent months. 18) participation in another study that may interfere with the results or conclusions of this study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT05787769
Study Brief:
Protocol Section:
NCT05787769