Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men

A Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of Testosterone Cypionate Injection in Hypogonadal Men

A Phase 4, multi-center, open-label, single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) study of Testosterone Cypionate Injection in Hypogonadal Men to assess change in 24-hour ambulatory blood pressure from Baseline to End of Treatment

Inclusion Criteria:

• Male subjects aged ≥18 to ≤75 years of age (inclusive) at time of enrollment.

• Body mass index (BMI) ≥17 kg/m^2 to < 40 mg^2.

• Willing and able to voluntarily provide written informed consent prior to initiation of screening or study-specific procedures.

• Able to understand and to follow the protocol requirements, restrictions, and instruction, in the Investigator's opinion

• Diagnosed with primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).

• Hypogonadal males (individual serum testosterone concentrations <350 ng/dL and mean serum testosterone concentrations <300 ng/dL, determined from at least two samples separated at least 48 hours apart and obtained between 6 AM and 10 AM local time).

• Testosterone therapy naïve or has discontinued current treatment and completed adequate washout of prior androgen therapy or any other therapy which causes significant change in serum androgen level i.e., clomiphene, anabolic steroids, compounded or over-the-counter androgenic steroid derivatives and dehydroepiandrosterone (45 days or 5 half-lives of the drug, whichever is longer, prior to collection of baseline serum testosterone samples). Washout must be completed prior to collection of baseline serum testosterone samples to determine study eligibility.

• An office blood pressure measurement <140 millimeters of mercury (mmHg) for SBP AND <90 mmHg for DBP.

• If the subject is on an antihypertensive regimen, he has been on stable dose for at least 4 weeks prior to study enrollment.

• If the subject is on glucocorticoids >7.5 mg prednisone equivalent per day (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg), he has been on stable dose for at least 4 weeks prior to study enrollment with no intention of changing dose for the duration of the study.

• Subjects with acceptable laboratory parameters

  1. Hematocrit ≤ Upper limit of normal (ULN)
  2. Hemoglobin ≤ 16 gm%
  3. Prolactin ≤ ULN
  4. PSA ≤ 4.0 ng/mL (PSA level between 1.5 to 4.0 ng/mL (both inclusive) for subject who is treated with 5-alpha reductase inhibitors (e.g., dutasteride, finasteride)
  5. HbA1c ≤ 9 %
  6. ALT ≤ 2.5 x ULN
  7. AST ≤ 2.5 x ULN
  8. Serum bilirubin ≤ 2.0 mg/dL

• No history of addiction to any recreational drug or drug dependence or alcohol abuse (including illicit steroid use) as per Investigator's judgement.

• Subject is not considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug.

• Subject is not currently enrolled in another clinical study and will not enroll in another clinical study throughout the duration of the study.

Exclusion Criteria:

• Subjects with known hypersensitivity to study drug, including androgens, or product excipients.
• Subjects with abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score > 19 points.
• Subjects with history of, or current or suspected, prostate or breast cancer.
• Subjects with history of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study enrollment except for diabetes, or renal disease
• Subject with history of fluid or electrolyte imbalance.
• Subject taking anticoagulant.
• Subjects with history of uncontrolled heart failure, stroke or myocardial infarction within the past 6 months.
• Subject with history of severe lower urinary tract symptoms in past 6 months.
• Subjects with history of diagnosed, severe, untreated, obstructive sleep apnea.
• Subjects working night shifts.
• Subjects performing strenuous manual labor or exercise while wearing the ABPM monitor.
• Subjects with chronic atrial fibrillation or any other chronic condition, which interferes with the ability to obtain precise ambulatory recordings.
• Subject with polycythemia.
• Subject with history of thrombophilia or venous thromboembolic events.
• Subject with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
• Participation in any clinical study within 45 days or 5 half-lives of the drug before dosing of Investigational Product.
• Loss of ≥ 350 ml (1 unit) of blood within 30 days of enrollment in the study.
• Any other medical condition or serious inter current illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study.