Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men

NCT03868059 | Completed Phase 3 Results FDA Drug

• 1 other identifier: LPCN 1021-18-001
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 16

Brief Summary

This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (1)

• Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)

  Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)

  Baseline to end of study (approximately 4 months).

Secondary Outcomes (17)

• Change in ABPM-measured Average Daytime SBP

  Baseline to End of Study (approximately 4 months)

• Change in ABPM-measured Average Nighttime SBP

  Baseline to End of Study (approximately 4 months)

• Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)

  Baseline to End of Study (approximately 4 months)

• Change in ABPM-measured Average Daytime DBP

  Baseline to End of Study (approximately 4 months)

• Change in ABPM-measured Average Nighttime DBP

  Baseline to End of Study (approximately 4 months)

Other Outcomes (8)

• Change is SBP Dip

  Baseline to End of Study (approximately 4 months)

• Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)

  Baseline to End of Study (approximately 4 months)

• Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS)

  Baseline to End of Study (approximately 4 months)

Study Arms (1)

LPCN 1021

EXPERIMENTAL

LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),

Drug: LPCN 1021

Interventions

LPCN 1021 DRUG

LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Also known as: TLANDO

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:

• Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
• Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65.
• Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
• Serum total T below lab normal range (300 ng/dL) based on two 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, if required.
• 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.
• Judged to be in good general health as determined by the investigator at screening.

You may not qualify if:

• History of significant sensitivity or allergy to androgens, or product excipients.
• Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
• Hemoglobin \< 11.5 g/dL or \> 16.5 g/dL
• Hematocrit \< 35% or \> 54%
• Serum transaminases \> 2.5 times upper limit of normal
• Serum bilirubin \> 2.0 mg/dL
• Creatinine \> 2.0 mg/dL
• PSA \> 4 ng/mL
• Prolactin \> 17.7 ng/mL.
• Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
• Subjects with screening systolic BP or diastolic BP above 160 mmHg or 100 mmHg, respectively.
• Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
• History of seizures or convulsions occurring after age 5, including alcohol or drug withdrawal seizures.
• 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.

Sponsors & Collaborators

• Lipocine Inc.: lead

Study Sites (16)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Neostart Corporation dba AGA Clinical Trials

Hialeah, Florida, 33012, United States

Location

Jacksonville Impotence Treatment Center

Jacksonville, Florida, 32223, United States

Location

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Manhattan Medical Research Practice PLLC

New York, New York, 10016, United States

Location

Aventiv Research, Inc.

Columbus, Ohio, 43213, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Granger Medical Clinic

West Valley City, Utah, 84096, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Related Publications (1)

• White WB, Dobs A, Carson C, DelConte A, Khera M, Miner M, Shahid M, Kim K, Chidambaram N. Effects of a Novel Oral Testosterone Undecanoate on Ambulatory Blood Pressure in Hypogonadal Men. J Cardiovasc Pharmacol Ther. 2021 Nov;26(6):630-637. doi: 10.1177/10742484211027394. Epub 2021 Jun 30.

  PMID: 34191621 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: Shadi Mehraban
• Organization: Lipocine

sm@lipocine.com

801-994-7383

Study Officials

• Anthony Delconte, MD

  Lipocine Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: February 21, 2019
• First Posted: March 8, 2019
• Study Start: April 30, 2018
• Primary Completion: February 19, 2019
• Study Completion: February 21, 2019
• Last Updated: June 10, 2021
• Results First Posted: June 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)