Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism

Antares Pharma

Status and phase: Completed; Phase 3

Conditions: Hypogonadism

Treatments: Combination Product: Testosterone enanthate auto-injector

Study type: Interventional

Funder types: Industry

Identifiers

NCT02504541

QST-15-005

Details and patient eligibility

About

Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.

Full description

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.

Enrollment: 133 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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133 participants in 1 patient group

Testosterone enanthate auto-injector

Experimental group

Description:

Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.

Treatment:

Combination Product: Testosterone enanthate auto-injector