Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Intervention: LPCN 1021
Intervention description: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

Eligibility 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).