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

Primary Purpose

Hypogonadism, Male

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
LPCN 1021
Sponsored by
Lipocine Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism, Male

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Oral testosterone undecanoate, LPCN 1021

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    August 3, 2017
    Last Updated
    October 11, 2019
    Sponsor
    Lipocine Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03242590
    Brief Title
    Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
    Acronym
    DV
    Official Title
    Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lipocine Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypogonadism, Male

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    95 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral testosterone undecanoate, LPCN 1021
    Arm Type
    Experimental
    Arm Description
    Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.
    Intervention Type
    Drug
    Intervention Name(s)
    LPCN 1021
    Intervention Description
    Oral testosterone undecanoate
    Primary Outcome Measure Information:
    Title
    Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
    Description
    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).
    Time Frame
    Following 24 days of treatment

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anthony DelConte, MD
    Organizational Affiliation
    Lipocine Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34994093
    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.
    Results Reference
    derived

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

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