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

Completed · Phase 3

Conditions studied: Hypogonadism, Male

In brief

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.

Key facts

Study ID

NCT03868059

Run by

Lipocine Inc.

People needed

138

Starts

2018-04-30

Expected to finish

2019-02-21

Last updated by the study team

2021-06-10

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

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.
• Known tolerability issues with ABPM devices.
• History of stroke, myocardial infarction, transient ischemic attack, or acute coronary syndrome within the past 5 years.
• History of long QT syndrome (or QTcB > 450) or unexplained sudden death (including cardiac death) or history of long QT syndrome in a first degree relative (parent, sibling, or child).
• Subjects who are not on stable dose of current medication (no changes in medication in the last 3 months).
• History of current or suspected prostate or breast cancer.
• History of untreated obstructive sleep apnea or not compliant with sleep apnea treatment.
• Active alcohol or any drug substance abuse, or history of abuse that will interfere with the subject's ability to participate in the study in the judgement of the investigator.
• Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study. A list of prohibited medications is provided in Appendix C.
• Use of any investigational drug within 5 half-lives of the last dose in the past 6 months prior to Study Day -2 without principal investigator and/or sponsor approval.
• Receipt of any investigational drug by injection within 30 days or 10 half-lives (whichever is longer) prior to study drug administration without principal investigator and/or sponsor approval.

Where it is running

• Alabama Clinical Therapeutics — Birmingham, Alabama, United States
• South Florida Medical Research — Aventura, Florida, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Neostart Corporation dba AGA Clinical Trials — Hialeah, Florida, United States
• Jacksonville Impotence Treatment Center — Jacksonville, Florida, United States
• Oviedo Medical Research, LLC — Oviedo, Florida, United States
• Clinical Research Center of Florida — Pompano Beach, Florida, United States
• Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
• Regional Urology — Shreveport, Louisiana, United States
• AccuMed Research Associates — Garden City, New York, United States
• Manhattan Medical Research Practice PLLC — New York, New York, United States
• Aventiv Research, Inc. — Columbus, Ohio, United States
• Prestige Clinical Research — Franklin, Ohio, United States
• Clinical Research Associates, Inc. — Nashville, Tennessee, United States
• Granger Medical Clinic — West Valley City, Utah, United States
• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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