Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism

Inclusion criteria

• Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
• Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples

Exclusion criteria

A subject will not be eligible for study participation if he meets any of the following criteria.

• History of significant sensitivity or allergy to androgens, castor oil or product excipients.
• Clinically significant findings in the prestudy examinations.
• Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score > 19 points.
• Body mass index (BMI) ≥ 38 kg/m2.
• Clinically significant abnormal laboratory values
• 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 seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
• 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 diagnosed, severe, untreated, obstructive sleep apnea.
• History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
• History of long QT syndrome or unexplained sudden death in a first degree relative (parent, sibling, or child).
• Concurrent treatment with medications which may impact the absorption, distribution, metabolism or excretion of testosterone undecanoate (TU) or place the subject at risk for treatment with testosterone.
• Subject has a partner who is currently pregnant or planning pregnancy during the course of the clinical trial.