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:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT04274894
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of hypogonadism with the presence of at least one of the following symptoms that may be related to low testosterone values and is/are consistent with hypogonadism:
* Decreased sexual desire or libido
* Decreased spontaneous erections (e.g. morning erections)
* Decreased energy or fatigue/feeling tired
* Low mood or depressed mood
* Loss of body (axillary and pubic) hair or reduced shaving
* Hot flashes AND
* Confirmed by 2 serum testosterone levels \< 300 ng/dL by blood samples drawn at least 48 hours apart. These samples should be obtained between 5 am and 11 am local time.
* Blood pressure \>100/60 mmHg and \<140/90 mmHg
Exclusion Criteria:
* Unprovoked deep vein thrombosis (DVT), unprovoked pulmonary embolism (PE), or known thrombophilia
* Polycythemia vera or secondary polycythemia, such as polycythemia due to untreated sleep apnea or severe chronic obstructive pulmonary disease
* Prostate or breast cancer
* Any active malignancy
* Clinically significant medical conditions or any other reason that the investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug
* Work night shifts or is otherwise required to perform strenuous manual labor while wearing the Ambulatory Blood Pressure Monitor (ABPM).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04274894
Study Brief:
Protocol Section:
NCT04274894