Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Intervention: Oral testosterone undecanoate; Transdermal testosterone gel (AndroGel)
Intervention description: Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID; Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD
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: 182.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this one year extension (follow-up) study is to gather additional safety data
      in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III
      study CLAR-09007.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects were to have completed Study CLAR-09007.

          2. Subjects were to have adequate venous access in the left or right arm to allow
             collection of a number of blood samples via a venous cannula.

          3. Subjects were required to remain off all forms of T except for study medication
             throughout the entire study.

          4. Subjects voluntarily gave written informed consent to participate in this study.

        Subjects meeting any of the following criteria were not eligible for participation in this
        study:

          1. Significant intercurrent disease of any type, in particular liver, kidney,
             uncontrolled or poorly controlled heart disease, or psychiatric illness developed
             during the Phase III study that would, in the opinion of the Investigator, require
             exclusion from this study.

          2. Untreated, severe obstructive sleep apnea (diagnosed during previous Phase III study).

          3. Serum transaminases >2 times upper limit of normal (ULN), serum bilirubin >2.0 mg/dL
             and serum creatinine >2.0 mg/dL at the final visit for Study CLAR 09007.

          4. Abnormal prostate digital rectal examination (palpable nodule[s]) or elevated PSA
             (serum PSA >4 ng/mL) at the final visit for Study CLAR-09007.

          5. Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary
             supplements that may increase serum T, such as androstenedione or
             dehydroepiandrosterone (DHEA).

          6. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors
             (e.g., orlistat [Xenical]) and bile acid-binding resins (e.g., cholestyramine
             [Questran], colestipol [Colestid]).

          7. Poor compliers with study medication, study procedures, or study visits in Study CLAR
             09007.

          8. Concomitant use of antiandrogens, estrogens, potent oral CYP3A4 inducers (e.g.,
             barbiturates, glucocorticoids [pharmacologic doses of glucocorticoids for replacement
             therapy were not exclusionary]) and potent CYP3A4 inhibitors (e.g., human
             immunodeficiency virus [HIV] antivirals [indinavir, nelfinavir, ritonavir, saquinavir,
             delaviridine], amiodarone, azithromycin, ciprofloxacin, ketoconazole). (Note:
             Short-term ciprofloxacin administration completed more than 7 days prior to study
             visits was not exclusionary during the study.)