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

Inclusion Criteria:

1. Documented diagnosis of primary hypogonadism (congenital or acquired) or
hypogonadotropic hypogonadism (congenital or acquired).

2. 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.

1. History of significant sensitivity or allergy to androgens, castor oil or product
excipients.

2. Clinically significant findings in the prestudy examinations.

3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS
score > 19 points.

4. Body mass index (BMI) ≥ 38 kg/m2.

5. Clinically significant abnormal laboratory values

6. 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).

7. History of seizures or convulsions, including febrile, alcohol or drug withdrawal
seizures.

8. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any
surgical procedure that might interfere with gastrointestinal motility, pH or
absorption.

9. History of any clinically significant illness, infection, or surgical procedure
within 1 month prior to study drug administration.

10. History of stroke or myocardial infarction within the past 5 years.

11. History of, or current or suspected, prostate or breast cancer.

12. History of diagnosed, severe, untreated, obstructive sleep apnea.

13. History of abuse of alcohol or any drug substance in the opinion of the investigator
within the previous 2 years.

14. History of long QT syndrome or unexplained sudden death in a first degree relative
(parent, sibling, or child).

15. 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.

16. Subject has a partner who is currently pregnant or planning pregnancy during the
course of the clinical trial.