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Trial record 1 of 1 for:    NCT03868059
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Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men

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ClinicalTrials.gov Identifier: NCT03868059
Recruitment Status : Completed
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Lipocine Inc.

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.

Condition or disease Intervention/treatment Phase
Hypogonadism, Male Drug: LPCN 1021 Phase 3

Detailed Description:

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.

The study is comprised of six scheduled visits: Visit 1 and 2 are for screening, Visit 3 is to assess subject's baseline BP and pulse rate (PR) via ABPM. Visit 4 is to enroll subjects, and to provide subjects with study medication for the start of dosing. Visit 5 is to assess subject's post-treatment BP and PR via ABPM. Visit 6 is to perform exit visit procedures.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : February 19, 2019
Actual Study Completion Date : February 21, 2019


Arm Intervention/treatment
Experimental: LPCN 1021
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
LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
Other Name: TLANDO




Primary Outcome Measures :
  1. Change in ambulatory blood pressure monitoring (ABPM) [ Time Frame: Baseline to end of study (approximately 4 months). ]
    Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) at Visit 3 to Visit 5.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65.
  3. Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
  4. 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.
  5. 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.
  6. Judged to be in good general health as determined by the investigator at screening.

Exclusion Criteria:

  1. History of significant sensitivity or allergy to androgens, or product excipients.
  2. Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:

    1. Hemoglobin < 11.5 g/dL or > 16.5 g/dL
    2. Hematocrit < 35% or > 54%
    3. Serum transaminases > 2.5 times upper limit of normal
    4. Serum bilirubin > 2.0 mg/dL
    5. Creatinine > 2.0 mg/dL
    6. PSA > 4 ng/mL
    7. Prolactin > 17.7 ng/mL.
  3. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
  4. Subjects with screening systolic BP or diastolic BP above 160 mmHg or 100 mmHg, respectively.
  5. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
  6. History of seizures or convulsions occurring after age 5, including alcohol or drug withdrawal seizures.
  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. Known tolerability issues with ABPM devices.
  10. History of stroke, myocardial infarction, transient ischemic attack, or acute coronary syndrome within the past 5 years.
  11. 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).
  12. Subjects who are not on stable dose of current medication (no changes in medication in the last 3 months).
  13. History of current or suspected prostate or breast cancer.
  14. History of untreated obstructive sleep apnea or not compliant with sleep apnea treatment.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. Subject who is not willing to use adequate contraception for the duration of the study.
  20. Any contraindications to a MRI scan (i.e. subjects with non-removable ferromagnetic implants, pacemakers, aneurysm clips or other foreign bodies), and/or subjects with claustrophobic symptoms and/or inability to fit into an MRI scanner.
  21. Inability to understand and provide written informed consent for the study.
  22. Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive LPCN 1021 (exact reason should be specified by the investigator).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868059


Locations
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United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Neostart Corporation dba AGA Clinical Trials
Hialeah, Florida, United States, 33012
Jacksonville Impotence Treatment Center
Jacksonville, Florida, United States, 32223
Oviedo Medical Research, LLC
Oviedo, Florida, United States, 32765
Clinical Research Center of Florida
Pompano Beach, Florida, United States, 33060
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Louisiana
Regional Urology
Shreveport, Louisiana, United States, 71106
United States, New York
AccuMed Research Associates
Garden City, New York, United States, 11530
Manhattan Medical Research Practice PLLC
New York, New York, United States, 10016
United States, Ohio
Aventiv Research, Inc.
Columbus, Ohio, United States, 43213
Prestige Clinical Research
Franklin, Ohio, United States, 45005
United States, Tennessee
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
United States, Utah
Granger Medical Clinic
West Valley City, Utah, United States, 84096
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Sponsors and Collaborators
Lipocine Inc.
Investigators
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Study Director: Anthony Delconte, MD Lipocine Inc.

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Responsible Party: Lipocine Inc.
ClinicalTrials.gov Identifier: NCT03868059     History of Changes
Other Study ID Numbers: LPCN 1021-18-001
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents