To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

The study was designed to determine if Androxal® would affect sperm parameters (count,
concentration, volume) in men with secondary hypogonadism who have been previously treated
with topical testosterone. A maximum of twelve subjects per group were randomized to daily
treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was
later amended to include a treatment group who received Androxal after a 3 month wash out
period.

Inclusion Criteria:

- Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.

- Subjects must have been treated with a topical testosterone replacement therapy
(typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more
than 2 years.

Exclusion Criteria:

- A history of idiopathic infertility due to primary hypogonadism, testicular failure,
Kallmann's syndrome or any other infertility condition.

- Subjects demonstrating any clinically significant medical condition rendering the
subjects infertile or marginally fertile other than AIHH.

- Men with a history of, known, or suspected prostate disease not ruled out by a
prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of
current prostate disease.

- Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl