A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months

Inclusion Criteria:

1. Subject must be a man 18 to 65 years of age, inclusive, with a previous clinicaldiagnosis of hypogonadism (signs/symptoms consistent with hypogonadism and a low Tlevel as defined by established criteria at the time of diagnosis); subjects mustalso have at least 1 T level < 300 ng/dL at either Screen 1 or Screen 2.

2. Subject must be naïve to androgen replacement therapy or washed out of priorandrogen replacement therapies (wash out durations specified in exclusioncriterion); that is, be willing to cease current T treatment, or currently not betaking T treatment.

3. Subject agrees as part of signed informed consent to remain off all forms of T,except for dispensed study drug, throughout the entire study.

4. Subject must have adequate venous access in the left or right arm to allowcollection of blood samples.

5. Subject must be able and willing to provide written informed consent and comply withthe trial protocol and procedures.

Exclusion Criteria:

• Subject will be excluded if 1 or more of the main exclusion is applicable:

1. Subject with a history of panhypopituitarism or multiple endocrine deficiencies (whether or not on stable doses of thyroid hormone and adrenal replacementhormones).

2. Subject with a current or prior history of AI.

3. Subject is currently receiving corticosteroids.

4. On the CST at Screen 3, the maximum serum total cortisol at both the 30- and 60-minute timepoint is ≤ 14 mcg/dL or has a baseline CBG outside the referencerange.

5. Subject with a history of a short course (2 weeks or less) of anyglucocorticoids within the past 3 months or anabolic steroids other thantestosterone within the past 6 months.

6. Subject with a history of a protracted course of any glucocorticoid therapy (e.g., inhaled nasal steroids, inhaled oral steroids, topical steroids,injectable steroids such as joint injections) or anabolic steroids other thanT. Enrolled subjects who take glucocorticoids while on study drug may bediscontinued from the study at the discretion of the investigator inconsultation with the sponsor.

7. Subject with a history of anabolic steroid abuse.

8. Subject with a diagnosis of hypogonadism who has received any topical (e.g.,gel or patch), intranasal, or buccal T therapy within the previous 2 weeks,intramuscular T injection of short-acting duration (e.g., T enanthate, Tcypionate) within the previous 4 weeks, intramuscular T injection oflong-acting duration (e.g., AVEED®) within the previous 20 weeks, T implantablepellets (Testopel®) product within the previous 6 months or any prior use of anoral testosterone product.

9. Subject has received any drug as part of another research study within 30 daysof initial dose administration in this study.

10. Subject has significant intercurrent disease (e.g., liver, kidney, inflammatorybowel disease, uncontrolled or poorly controlled heart disease, includinghypertension, thromboembolism, congestive heart failure, or coronary heartdisease, psychiatric illness, including severe depression), which in theopinion of the Investigator, would affect study participation or interpretationof study assessments.

11. Subject has untreated, severe obstructive sleep apnea.

12. Subject has clinically significant abnormal laboratory values, including serumtransaminases > 2 × upper limits of normal (ULN), serum bilirubin > 1.5 × ULN (except subjects with Gilbert syndrome) and serum creatinine > 1.5 × ULN.

13. Subject has a HCT value of < 35% or > 50%.

14. Subject has a history of polycythemia, either idiopathic or associated with TRTtreatment.

15. Subject is diabetic with a glycosylated hemoglobin > 8.5%.

16. Subject has a body mass index (BMI) ≥ 38 kg/m2.

17. Subject has had a recent (within 2 years) history of stroke, transient ischemicattack, or acute coronary event.

18. Subject has a mean (triplicate assessments) systolic blood pressure (sBP) > 140mm Hg and/or diastolic blood pressure (dBP) > 90 mm Hg at screening (ifprescribed antihypertensives, subject should be taking medications on the dayof the screening visit with a sip of water).

19. Subject has had recent (within 2 years) history of angina or stent (coronary orcarotid) placement.

20. Subject does not meet the requirements for concomitant medication as outlinedbelow:

21. If hypertensive, on a stable dose of antihypertensive medication for < 3months

22. If diabetic, on a stable dose of oral medication for < 2 months

23. If on anticonvulsant therapy, on a stable dose for < 3 months

24. If on lipid lowering medications, on a stable dose for < 3 months. Subjectis expected to remain on a stable dose of lipid-lowering medication(s)throughout the study.

25. Subject has an abnormal prostate DRE (palpable nodules), elevated PSA (serumPSA > 4.0 ng/mL), I-PSS > 19 points at screening.

26. Subject has a history of, or current or suspected prostate cancer.

27. Subject has a history of, or current or suspected breast cancer.

28. Subject currently using a drug known to affect T levels, T metabolism or levelsof T metabolites. These include: 5-alpha-reductase inhibitors (e.g.,dutasteride, finasteride), estrogens, long-acting opioid analgesics (e.g.,methadone hydrochloride, buprenorphine hydrochloride), human growth hormone (HGH) or over-the-counter supplements purported to "boost" testosterone, sexualfunction or improve prostate symptoms.

29. Subject use of dietary supplements such as saw palmetto or phytoestrogens andany dietary supplements that may increase total T, such as androstenedione ordehydroepiandrosterone within the previous 4 weeks.

30. Subject use of any over-the-counter "adrenal supplements".

31. Subject is not willing to stop all supplemental biotin 3 days prior to testingat intervals described in this protocol.

32. Subject currently using Megace, atypical anti-psychotics (e.g., clozapine,aripiorazole, asenapine, lumateperone, olanzapine, paliperidone, aripiprazole,ziprasidone, cariprazine, risperidone, pimavanserin, ioperidone, brexpiprazole,lurasidone, quetiapine) or chronic benzodiazepine use.

33. Subject has a history of abnormal bleeding tendencies or thrombophlebitisunrelated to venipuncture or intravenous cannulation within the previous 2years.

34. Subject has history of abuse of alcohol or any drug substance within theprevious 2 years.

35. Subject deemed to be a compliance risk or unlikely to keep clinic appointments.

36. Subject donated blood (≥ 500 mL) within the 12-week period before the initialstudy dose.