The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an
eye exam. Blood samples are required at all visits including sampling every hour for a 24
hour time period during the 2 overnight stays. A six month extension study will be available
for all subjects completing the 6-week study.

Inclusion Criteria:

- Healthy males between the ages of 18 and 65 years of age exhibiting morning
testosterone ≤350 ng/dL.

- All clinical laboratory tests within normal ranges (any clinically significant
deviation of laboratory results will require approval of sponsor)

- Ability to complete the study in compliance with the protocol

- Ability to understand and provide written informed consent

- Agreement to use a condom, and with a fertile female partner, another form of
contraception.

- Agreement to provide a semen sample in the clinic

Exclusion Criteria:

- Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3
months prior to study

- Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen,
anabolic steroid, DHEA, or herbal hormone products during the study

- Use of Clomid in the past year or during the study

- Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment
at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control
will be allowed into the study. Newly diagnosed diabetics need to be treated for at
least 48 hours before being enrolled in the study.

- A hematocrit ≥51 % or a hemoglobin ≥17 g/dL

- Clinically significant abnormal findings on screening examination

- Use of an investigational drug or product, or participation in a drug or medical
device research study within 30 days prior to receiving study medication

- Known hypersensitivity to Clomid

- Any condition which in the opinion of the investigator would interfere with the
participant's ability to provide informed consent, comply with study instructions,
possibly confound interpretation of study results, or endanger the participant if he
took part in the study

- Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome,
primary hypogonadism, vasectomy, or tumors of the pituitary)

- History of breast cancer

- History of prostate cancer or a suspicion of prostate disease unless ruled out by
prostate biopsy, or a PSA >3.6

- History of known hyperprolactinemia with or without a tumor

- Chronic use of medications use such as glucocorticoids

- Chronic use of narcotics

- Subjects known to be positive for HIV

- Subjects with end stage renal disease

- Subjects with cystic fibrosis (mutation of the CFTR gene)

- Subjects unable to provide a semen sample in the clinic

- Subject has a BMI >42 kg/m2