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 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT07270432
Eligibility Criteria:
Inclusion Criteria:
* Male participants aged 50 years and older.
* Ability to understand the study and provide informed consent, documented by signing the Informed Consent Form (ICF).
* Participants presenting lower urinary tract symptoms (LUTS) associated with prostate enlargement, without neurological or infectious causes.
Exclusion Criteria:
* History or evidence of prostate cancer.
* Urinary retention ≥100 mL, as assessed by abdominal prostate ultrasound.
* Previous diagnosis of Parkinson's disease or other neurological disorders that may lead to neurogenic bladder.
* Use of herbal treatments for prostate enlargement within 14 days prior to the screening visit.
* Current use or use of alpha-blocker medications within 7 days prior to the start of study treatment.
* Current use or use of 5-alpha reductase inhibitors (5ARIs) within 180 days prior to the start of study treatment.
* Use of any prohibited medications within the timeframe specified in the study protocol.
* Any clinical findings or observations (clinical or physical evaluation) that, in the investigator's judgment, pose a risk to participation in the study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT07270432
Study Brief:
Protocol Section:
NCT07270432