Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism

Intended users are patients as well as patient caregivers, such as family members or friends who are able to assist the patient to administer the medication (i.e. lay users). One user group of approximately 15 patients will have their dose administered by a qualified healthcare professional (HCP).

Inclusion criteria

Each patient must meet all of the following criteria at screening to participate in the study:

• The patient is 18 years of age or older;
• The patient speaks, reads, and understands the English language at a sixth grade reading level or higher;
• The patient is willing to have photographs taken and/or be video recorded while he completes study tasks, which will be de-identified prior to any potential use of the image(s) for scientific or educational purposes;
• The patient has sufficient availability to participate in the study and to comply with the study schedule;
• The patient has his own transportation to and from the study site;
• The patient demonstrates the ability to understand and the willingness to follow all study instructions; and
• The patient has read, stated he understands, and has signed the Informed Consent Form (ICF).
• The patient has been diagnosed with hypogonadism;
• The patient is a male;
• The patient has a documented history of hypogonadism. Diagnosis must include documentation of consistent signs and symptoms of androgen deficiency;
• Patients in good health as determined by the Investigator and based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests;
• All male patients must practice effective contraception during the study and for 30 days after receiving the last dose of study drug. Acceptable methods of birth control include condom with spermicide, vasectomy, or monogamous relations with a female partner who is of non child-bearing potential (post-menopausal, surgical, or congenital sterility) or is of child bearing potential and practicing a reliable method of contraception (hormonal contraception, double barrier methods with spermicide, or intrauterine device); and
• Patients must have the ability to provide written informed consent and comply with all study requirements and restrictions including the study visit schedule.

Exclusion criteria

Patients will be excluded from participation in the study if any of the following criteria apply:

• Failure to meet 1 or more Inclusion Criterion;
• The patient has participated in interviews, focus groups, or studies for any medical products or therapies within the past 3 months or in a prior QST auto-injector usability study, clinical trial, and/or has previous exposure to the investigational device;
• The patient or someone he lives with works or has worked for a Marketing/Market Research Company, pharmaceutical or medical device company, a manufacturer, distributor, or wholesaler of non-prescription drug products, or a government health agency;
• Individuals who have had an allergic reaction or idiosyncratic reaction to sesame seeds, sesame products, and/or sesame oil;
• History of food anaphylaxis;
• History of intolerance, allergy, or idiosyncratic reaction to testosterone products;
• Unstable psychiatric illnesses;
• Lifetime history of psychosis, suicidal behavior, bipolar disorder, or personality disorder; active suicidal ideation within 6 months prior to screening; or inadequately treated depression. Note: Patients with depression who have been adequately treated and with stable response for 3 months may be admitted into the study at the Investigator's discretion;
• Body mass index 40 kg/m2;
• Hematocrit 52% at Initial Screening Visit;
• Individual history or current evidence of breast or prostate cancer;
• Other malignancy diagnosed or treated within 5 years of the date of Initial Screening Visit with the exception of non-melanoma carcinoma of the skin;
• Elevated prostate-specific antigen (PSA) for age. Prostate-specific antigen 2.5 ng/mL in men 18 to 60 years old and 4 ng/mL in men 61 years and older is exclusionary;
• Presence of prostate nodule or induration upon digital rectal exam;
• Obstructive uropathy of prostatic origin and of a severity that, in the opinion of the Investigator, contraindicates the use of testosterone;
• Patients with poorly controlled diabetes. Patients on a stable dose and regimen of anti diabetic medications for a minimum of 4 weeks, and who have a hemoglobin A1c level of 7.5% may participate in the study;
• Patients with New York Heart Association Class III or IV congestive heart failure;
• Within 6 months of the Initial Screening Visit, have had myocardial infarction, 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 of, or current treatment for, thromboembolic disease or current use of anti thromboembolic medications. Use of low-dose aspirin is permitted for routine cardioprophylaxis;
• Patients intermittently taking adrenocorticotropic hormone, oral, or depot corticosteroids (ongoing regimens required for panhypopituitarism or adrenal failure are permitted);
• Untreated sleep apnea;
• Historical or current evidence of any clinically significant disease or disorder that, in the judgment of the Investigator, may cause participation in this study to be detrimental to the patient or which may influence the results of the study. This includes cardiovascular, renal, hepatic, hematological, endocrine, gastrointestinal, or pulmonary disease;
• Positive serology for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibody at the Initial Screening Visit;
• Current evidence of alcohol or drug abuse. A positive drug screen is exclusionary without documentation of a current prescription and medical condition requiring treatment with the drug for which the screen is positive. Exception: tetrahydrocannabinol is allowed in states where recreational use of marijuana is legal;
• Any skin condition that could confound injection site assessments (eg, dermatographism, urticaria, or atopic dermatitis). Tattoos, scarring, or psoriasis of the injection site is prohibited;
• Administration of any other investigational compound within 1 month prior to Initial Screening Visit or 5 half-lives of the investigational product (whichever is longer);
• Patients considering or scheduled to undergo any major surgery or dental procedure anticipated to be associated with significant blood loss (500 mL) during the study;
• Systolic blood pressure (SBP) 140 mmHg and/or diastolic blood pressure (DBP) 90 mmHg at the Initial Screening Visit. Patients with treated hypertension and SBP 140 and/or DBP 90 mmHg at the Initial Screening Visit must be on a stable dose of antihypertensive medication for at least 14 days at Day -1 (Baseline Visit) and plan to remain on the same dose throughout the duration of the study; or
• Unable to understand verbal or written English or any other language in which a certified translation of the informed consent is available.