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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT03313635
Eligibility Criteria:
Inclusion Criteria:
* Provide responses to standard questionnaires administered to subjects
* Written Informed Consent obtained
* Male sex at birth
* ≥ 40 and ≤ 75 years of age
* Presentation to the clinic with symptoms suggestive of low testosterone such as loss of libido, erectile dysfunction, cognitive or mood disturbances, etc.
* Able and willing to provide blood specimens and follow study schedule
* A final diagnosis can be established (androgen deficient versus not androgen deficient)
Exclusion Criteria:
* Previous exposure to exogenous T, DHEA, clomiphen citrate, or other Selective Estrogen Receptor Modulators, or OTC or herbals (Treatment Naïve)
* Use of opioid medication within 3 months prior to enrollment
* Serious psychiatric disease or uncontrolled medical illness, as suspected from medical history or clinical examination
* Use of any sex hormones or steroidal anabolic drug supplements (OTC or prescribed)(Treatment Naïve)
* Incapable of giving informed consent or complying with protocol or unwilling to comply with protocol requirements
* Diagnosis of prolactinoma
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03313635
Study Brief:
Protocol Section:
NCT03313635