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

NCT03242590 | Completed Phase 3 Results FDA Drug

• 1 other identifier: LPCN 1021-16-002
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (1)

• Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range

  The primary efficacy endpoint and analysis for this study was the percentage of LPCN 1021 treated subjects who had achieved a 24-hour average serum T concentration within the normal range of 300 to 1080 ng/dL at Visit 4, (Day 24 ± 4 days).

  Following 24 days of treatment

Study Arms (1)

Oral testosterone undecanoate, LPCN 1021

EXPERIMENTAL

Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.

Drug: LPCN 1021

Interventions

LPCN 1021 DRUG

Oral testosterone undecanoate

Oral testosterone undecanoate, LPCN 1021

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lipocine Inc.: lead

Related Publications (1)

• 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.

  PMID: 34994093 DERIVED

MeSH Terms

Conditions

Eunuchism

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Nachiappan Chidambaram, Vice President, Product Development
• Organization: Lipocine, INC.

nc@lipocine.com

8018819495

Study Officials

• Anthony DelConte, MD

  Lipocine Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 8, 2017
• Study Start: December 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 23, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share