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Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) (DF)

Primary Purpose

Hypogonadism, Male

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

LPCN 1021

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:

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).

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 150 mg TU three 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

Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration [Cavg] in the normal range

Secondary Outcome Measures

Full Information

NCT ID

NCT03242408

First Posted

August 3, 2017

Last Updated

October 11, 2019

Sponsor

Lipocine Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03242408

Brief Title

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

Acronym

Official Title

Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

May 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

Data Monitoring Committee

5. Study Description

Brief Summary

This is a 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

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral testosterone undecanoate, LPCN 1021

Arm Type

Experimental

Arm Description

Oral testosterone undecanoate, LPCN 1021 150 mg TU three 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

Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration [Cavg] in the normal range

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

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

Learn more about this trial

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

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