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:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
NCT ID:
NCT07290400
Eligibility Criteria:
Inclusion Criteria:
* Male adults 21 to 65 years of age, inclusive
* Documented history of erectile dysfunction for at least 6 months, as determined by the investigator
* In a stable sexual relationship and willing to attempt sexual activity as required by study procedures, if applicable
* Medically stable based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator
* Able, in the investigator's judgment, to safely consume moderate amounts of alcohol as defined in the protocol
* Willing to abstain from alcohol outside of protocol-specified intake during the study
* Able to understand and provide written informed consent before any study-specific procedures are performed
* Willing and able to comply with all study procedures, including dosing, washout periods, pharmacokinetic sampling, onset assessments, and safety monitoring
Exclusion Criteria:
* Known hypersensitivity or contraindication to sildenafil, other PDE5 inhibitors, alcohol, or any component of the Hezkue® formulation
* Use of nitrates, nitric oxide donors, guanylate cyclase stimulators (such as riociguat), or other prohibited medications within a protocol-defined period
* Clinically significant cardiovascular disease, including coronary artery disease, heart failure, clinically important arrhythmias, recent stroke, or uncontrolled hypertension or hypotension
* Resting blood pressure or heart rate outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator
* Significant hepatic, renal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that could increase risk or interfere with study assessments
* History of syncope, significant orthostatic hypotension, or other conditions that may be worsened by sildenafil or alcohol
* History of alcohol use disorder, binge drinking, or other substance use disorder, as determined by the investigator
* Positive urine drug screen or positive alcohol test at screening or admission (outside protocol-specified alcohol administration)
* Use of prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before first dosing unless approved by the investigator
* Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV
* Participation in another clinical study or receipt of an investigational product within 30 days or 5 half-lives, whichever is longer
* Donation of 450 mL or more of blood, or significant blood loss, within 8 weeks before first dosing
* Any condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable or interfere with study conduct or interpretation
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07290400
Study Brief:
Protocol Section:
NCT07290400