Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
Condition: Hypogonadism; Primary Hypogonadism; Secondary Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone Undecanoate 750 mg; Testosterone Undecanoate 1000 mg
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 531.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: investigational; testosterone; testosterone undecanoate; TU; Hypogonadism; primary hypogonadism; secondary hypogonadism

Summary:

      To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of
      serum total testosterone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male with primary or secondary hypogonadism at least 18 years of age and for study
             part C2 weighs ≥143.3 lb (≥65 kg)

          -  Morning screening serum testosterone concentration <300 ng/dL

        Exclusion Criteria:

          -  American Urological Association (AUA) Symptom Score ≥15 or significant prostatic
             symptoms

          -  History of carcinoma, tumors or induration of the prostate or the male mammary gland
             including suspicion thereof

          -  Screening serum prostate-specific antigen (PSA) level >4 ng/mL or hyperplasia of the
             prostate (size >75 cm3 as measured by transrectal ultrasonography)

          -  Past or present liver tumors or acute or chronic hepatic disease with impairment of
             liver function; liver function tests (alanine aminotransferase [ALT], aspartate
             aminotransferase [AST]) exceeding 1.5 times upper limit of normal

          -  History of deep vein thrombosis in the past 5 years or any history of cerebrovascular
             accident

          -  Severe acne

          -  Hypertension (systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm
             Hg) or coronary heart disease not stabilized by therapy as assessed by the
             investigator

          -  Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes
             mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C)
             level is >9%

          -  Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7
             days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit
             and throughout the study (exclusive of administered study drug)

          -  Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone [DHEA]) by
             any application method within the 28 days prior to first administration of study drug
             and throughout the study (exclusive of administrated study drug)

          -  Medication with substances which might interfere with testosterone metabolism within
             28 days before the first administration of study drug

          -  History of sleep apnea Insulin-dependent diabetes mellitus

          -  Use of steroidal anabolic drugs or supplements by any application method within the
             28-days prior to the first administration of the study drug and throughout the study
             (exclusive of the administered study drug)