Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)

Inclusion criteria

• Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy.
• Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
• Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.

Exclusion criteria

• History of significant sensitivity or allergy to androgens, or product excipients.
• Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
• Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).
• Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
• Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis
• Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab).
• History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
• History of any clinically significant illness, infection, or surgical procedure within 1 month 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 untreated and severe obstructive sleep apnea.
• History of long QT syndrome (QTc > 450) or unexplained sudden death in a first degree relative (parent, sibling, or child).