Status:
COMPLETED
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Lead Sponsor:
Lipocine Inc.
Conditions:
Hypogonadism, Male
Eligibility:
MALE
18-80 years
Phase:
PHASE3
Brief Summary
Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03242590
Start Date
December 1 2016
End Date
July 1 2017
Last Update
October 23 2019
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