Clinical Trial Summary

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Phase

Phase 4

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Funding Agency/Sponsor

Other

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Disease

Other

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Enrollment Eligibility

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. Documented diagnosis of primary hypogonadism (congenital or acquired) or
hypogonadotropic hypogonadism (congenital or acquired).
3. Serum total testosterone < 300 ng/dL on 2 measurements
4. Naïve to androgen replacement or has discontinued current treatment and completed a
washout of 4 months following androgen treatment.
5. Men deemed to be candidates for TRT based on the results of a medical history,
physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram
(ECG).
Exclusion Criteria:
1. History of significant sensitivity or allergy to androgens, or product excipients.
2. Clinically significant findings in the pre-study examinations including abnormal
breast examination requiring follow-up, abnormal ECG.
3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s)
4. Body mass index (BMI) ≥ 40 kg/m2.
5. Clinically significant abnormal laboratory value, in the opinion of the investigator,
in serum chemistry, hematology, or urinalysis including but not limited to:
1. Baseline hemoglobin > 16 g/dL or HCT 48%
2. PSA > 4 ng/mL
6. History of seizures or convulsions, including febrile, alcohol or drug withdrawal
seizures.
7. History of any clinically significant illness, infection, or surgical procedure within
4 weeks prior to study drug administration.
8. History of stroke or myocardial infarction within the past 5 years.
9. History of, or current or suspected, prostate or breast cancer.
10. History of diagnosed, severe, untreated, obstructive sleep apnea.
11. History of abuse of alcohol or any drug substance in the opinion of the investigator
within the previous 2 years.
12. Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt
of a transfusion of any blood product within 12 weeks prior to the start of treatment.
13. Inadequate venous access for collection of serial blood samples required for
pharmacokinetic profiles.
14. Receipt of any subcutaneous testosterone pellets within the last 6 months.
15. Inability to understand and provide written informed consent for the study.

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