Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

This is the long-term extension of Study CLAR-09007, which like Study CLAR-09007, is an
open-label study. This study contained an arm to evaluate the oral TU formulation as well as
a comparator arm of the market-leading transdermal T-gel formulation. The comparator arm was
included in the Phase III study and in this extension study to allow a general evaluation of
comparative safety. Subjects randomized to oral TU in the Phase III study were continued on
oral TU in the extension, and those who completed this 12-month Phase IV study have been
followed for a total of 2 years of oral TU therapy. Likewise, subjects randomized to
transdermal T-gel in the Phase III study were continued on T-gel in the extension, and those
who completed this 12-month Phase IV study have been followed for a total of 2 years of T gel
therapy. This 2-year period of therapy and assessments was to provide a long-term view of the
safety of oral TU and the stability of the T replacement.

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.)