Clinical trial NCT03242590: Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Official title: Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism, Male
Lead sponsor: Lipocine Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 95
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
3. 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:

1. History of significant sensitivity or allergy to androgens, or product excipients.
2. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).
4. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
5. Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis
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 gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
8. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
9. History of stroke or myocardial infarction within the past 5 years.
10. History of or current or suspected prostate or breast cancer.
11. History of untreated and severe obstructive sleep apnea.
12. History of long QT syndrome (QTc \> 450) or unexplained sudden death in a first degree relative (parent, sibling, or child).

Primary outcomes:
measure: Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
timeFrame: Following 24 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lipocine Inc.
name: Anthony DelConte, MD
role: STUDY_DIRECTOR
References:
citation: DelConte A, Papangkorn K, Kim K, Bruno BJ, Chidambaram N, Khera M, Goldstein I, Kohler TS, Miner M, Dobs AS, Patel MV. A new oral testosterone (TLANDO) treatment regimen without dose titration requirement for male hypogonadism. Andrology. 2022 May;10(4):669-676. doi: 10.1111/andr.13153. Epub 2022 Jan 18.