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 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT06312761
Eligibility Criteria:
Inclusion Criteria:
* 1\. healthy male between 18 and 55 years of age
* 2\. agrees to not participate in another drug research study for the duration of this study
* 3\. agrees to not donate blood during the study
* 4\. subject provided written (personally signed and dated) informed consent before completing any study-related procedures
* 5\. subject able and willing to comply with the protocol
* 6\. subject able and willing to not take medications other than the study drug for the duration of the study
Exclusion Criteria:
* 1\. subject has poor general health, determined by medical history or physical exam
* 2\. subject have an abnormal evaluation on screening exam (consisting of serum chemistry, hematology and baseline hormone levels)
* 3\. subject have a known history or current use of alcohol drug or steroid abuse and/or the use of more than 3 alcoholic beverages per day
* 4\. History of current testosterone use
* 5\. History of testicular disease or severe testicular trauma
* 6\. History of major psychiatric disorder
* 7\. subject participated in a hormonal drug study within the past month
* 8\. Subject or his partner(s) NOT willing to use an accepted method of contraception during the study
* 9\. History of Bleeding disorders or current use of anti-coagulants
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06312761
Study Brief:
Protocol Section:
NCT06312761