Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters

Inclusion Criteria:

• Voluntarily sign and date the study consent form(s) which have been approved by anInstitutional Review Board (IRB). Written consent must be obtained prior to theinitiation of any study procedures.
• Male between 18 and 55 years of age, inclusive, with documented onset of hypogonadismprior to age 55.
• Documented diagnosis of primary hypogonadism (congenital or acquired) orhypogonadotropic hypogonadism (congenital or acquired).
• Serum total testosterone < 350 ng/dL based on 2 consecutive blood samples obtained atleast 1.5 hours apart between 6:00 am and 10:00 am following an appropriate washout ofcurrent androgen replacement therapy.
• Naïve to androgen replacement or has discontinued current treatment and completed awashout of 4 weeks following androgen treatment (excluding Testopel). Washout must becompleted prior to collection of baseline serum testosterone samples to determinestudy eligibility.
• Judged to be in good general health as determined by the principal investigator basedupon the results of a medical history, physical examination, vital signs, laboratoryprofile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

• History of significant sensitivity or allergy to androgens, castor oil or productexcipients.
• Clinically significant findings in the prestudy examinations including abnormal breastexamination requiring follow-up, abnormal ECG.
• Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) orInternational Prostate Symptoms Score (I-PSS) > 19 points.
• Body mass index (BMI) ≥ 30 kg/m2.
• Clinically significant abnormal laboratory value, in the opinion of the investigator,in serum chemistry, hematology, or urinalysis including but not limited to:

1. Baseline hemoglobin < 11.5 g/dL or > 16 g/dL
2. Hematocrit < 35% or > 54%
3. Serum transaminases > 2.5 times upper limit of normal
4. Serum bilirubin > 2.0 mg/dL
5. Creatinine > 2.0 mg/dL f. Prostate-Specific Antigen (PSA) > 2 ng/mL

• History of seizures or convulsions, including febrile, alcohol or drug withdrawalseizures.
• History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
• History of stroke or myocardial infarction within the past 5 years.
• History of, or current or suspected, prostate or breast cancer.
• History of diagnosed, severe, untreated, obstructive sleep apnea.
• History of abuse of alcohol or any drug substance in the opinion of the investigatorwithin the previous 2 years.
• Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receiptof a transfusion of any blood product within 12 weeks prior to the start of treatment.
• Inadequate venous access for collection of serial blood samples required forpharmacokinetic profiles.
• Receipt of any investigational product within 4 weeks or within 5 half-lives prior tothe start of treatment.
• Inability to understand and provide written informed consent for the study.
• Considered by the investigator or the sponsor-designated physician, for any reason,that the subject is an unsuitable candidate to receive Natesto.