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

• Sponsor: Lipocine Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03242590
• Collaborator: (none)
• Enrollment: 95
• Arm: 1
• Actual Duration (Months): 7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism, Male	Drug: LPCN 1021	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral testosterone undecanoate, LPCN 1021 Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.	Drug: LPCN 1021; Oral testosterone undecanoate

Outcome Measures

Primary Outcome Measures

1. Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range [Following 24 days of treatment]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Lipocine Inc.

Investigators

• Study Director: Anthony DelConte, MD, Lipocine Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 24, 2017

More Information

Publications

None provided.

• Responsible Party: Lipocine Inc.
• ClinicalTrials.gov Identifier: NCT03242590
• Other Study ID Numbers: LPCN 1021-16-002
• First Posted: Aug 8, 2017
• Last Update Posted: Oct 23, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypogonadism; Eunuchism; Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate

Study Results

Participant Flow

Arm/Group Title	Oral Testosterone Undecanoate, LPCN 1021
Arm/Group Description	Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
Period Title: Overall Study
STARTED	95
COMPLETED	95
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Oral Testosterone Undecanoate, LPCN 1021
Arm/Group Description	Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
Overall Participants	95
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.0 (8.9)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	95 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 1.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	15 15.8%
White	77 81.1%
More than one race	2 2.1%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	95 100%
Baseline Testosterone Value (ng/dL) (ng/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/dL]	202 (74.5)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Oral Testosterone Undecanoate, LPCN 1021
Arm/Group Description	Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
Measure Participants	95
Number (95% Confidence Interval) [Percent of participants]	80 84.2%

Adverse Events

Time Frame	1 month
Arm/Group Title	Oral Testosterone Undecanoate, LPCN 1021
Arm/Group Description	Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
All Cause Mortality
	Oral Testosterone Undecanoate, LPCN 1021
	Affected / at Risk (%)	# Events
Total	0/95 (0%)
Serious Adverse Events
	Oral Testosterone Undecanoate, LPCN 1021
	Affected / at Risk (%)	# Events
Total	1/95 (1.1%)
Gastrointestinal disorders
Gastric Ulcer Hemorrhage	1/95 (1.1%)	1
Other (Not Including Serious) Adverse Events
	Oral Testosterone Undecanoate, LPCN 1021
	Affected / at Risk (%)	# Events
Total	6/95 (6.3%)
Endocrine disorders
Blood prolactin increased	4/95 (4.2%)	4
Blood FSH decreased	1/95 (1.1%)	1
Blood LH decreased	1/95 (1.1%)	1
Investigations
PSA increased	1/95 (1.1%)	1
Weight increased	1/95 (1.1%)	1
Nervous system disorders
Headache	1/95 (1.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.