Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Antares Pharma Inc.
Safety assessments, including laboratory assessments, adverse events and injection site assessments, will be conducted for all patients at scheduled intervals during the Treatment Titration Period.
Age
18–75
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Adult men ≥18 and ≤75 years of age with a documented history of hypogonadism
Total testosterone levels \< 300 ng/dL at two qualification visits
Patients in good general health
You may not be if
Allergy to sesame or testosterone products
BMI ≥ 40 kg/m2
Hematocrit ≥ 52%
History or current evidence of breast or prostate cancer
Elevated prostate-specific antigen (PSA) for age.
Abnormal digital rectal examination (DRE)
Unstable psychiatric illnesses
Obstructive uropathy of prostatic origin
Poorly controlled diabetes
Congestive heart failure
Within 6 months of screening, myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.
History or current treatment of thromboembolic disease.
Use of adrenocorticotropic hormone (ACTH) or oral/depot corticosteroids within 6 weeks of screening.
History of severe, untreated sleep apnea
Subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study
Positive serology for HIV, hepatitis B or hepatitis C
Current evidence of drug or alcohol abuse.
Skin conditions in injection site that could confound injection site assessments.
Administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer).
Use of estrogen, gonadotropin-releasing hormone (GnRH) or growth hormone within 12 months of screening.
Use of other androgens (DHEA), anabolic steroids, other sex hormones) or other substances/supplements know to affect the pharmacokinetics (PK) of testosterone enanthate
Considered or scheduled surgical or dental procedures associated with blood loss ≥500 mL during study.
Donation of plasma or blood within 56 days of screening or history of donation of \> 50 mL of blood or plasma within 3 months of screening.
Donation of plasma or blood during study
Clareo Health | Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
