A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%

Inclusion Criteria:

- Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive

- Previously or concurrently diagnosed as having secondary hypogonadism characterized
as having at least 2 consecutive morning testosterone assessments < 300ng/dL, one of
which must be confirmed at Baseline.

- LH < 9.4 mIU/mL (at Visit 1 only)

- Sperm concentration ≥ 15 million per milliliter (assessed at V2 and Baseline). V2 and
Baseline measurements must be at least 48 hours apart.

- Ability to complete the study in compliance with the protocol

- Ability to understand and provide written informed consent

- Agreement to provide a total of at least 4 semen samples in a sponsor-approved clinic
on 4 separate occasions.

Exclusion Criteria:

- Any prior use of testosterone treatments (injectable, pelleted, transdermal or
sublingual) within the last 6 months

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

- Use of Clomid in the past year

- Any clinically significant laboratory abnormality that does not have prior written
sponsor approval. If the sponsor approves subject enrollment, this will not be
considered to be a protocol deviation.

- Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment
at baseline. Subjects treated for Type II diabetes will be allowed into the study,
if considered clinically stable by the investigator. Newly diagnosed diabetics need
to be treated for at least 48 hours before being enrolled in the study.

- A hematocrit >54

- 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

- Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2
based on 0-4 scale or any evidence of posterior subcapsular cataract)

- Abnormal fundoscopy exam such as central retinal vein occlusion

- 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

- Have received a diagnosis of irreversible infertility or compromised fertility
(cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the
pituitary), or history of evaluation or treatment for low fertility

- Current or history of breast cancer

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

- Presence or history of known hyperprolactinemia with or without a tumor (prolactin >
20 ng/mL).

- Chronic use of medications such as glucocorticoids (chronic use of inhaled or topical
glucocorticoids is acceptable)

- History of drug abuse or chronic narcotic use including methadone

- A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or
presence of moderate alcohol use (>21 drinks per week)

- Subjects with known history of HIV and/or Hepatitis C

- Subjects with end stage renal disease

- History of liver disease (including malignancy) or a confirmed AST or ALT >3 times
the upper limit of normal

- History of clinically relevant myocardial infarction (within the previous year),
unstable angina, symptomatic heart failure, ventricular dysrhythmia or know history
of QTc interval prolongation

- History of clinically relevant cerebrovascular disease

- History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary
embolism)

- History of erythrocytosis or polycythemia

- Subjects unable to provide a semen sample in a sponsor-approved clinic

- Enrollment in a previous Androxal study

- Subjects who have Type I Diabetes