Patient Satisfaction After Switching to Oral Testosterone Undecanoate

Inclusion Criteria

• 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.
• Males between 18 and 65 years of age.
• Documented diagnosis of testosterone deficiency.
• Prior treatment with testosterone therapy at the time of enrollment with adequate control of low testosterone symptoms. Serum total testosterone 19 points.
• Body mass index (BMI) ≥ 40 kg/m2.
• Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
• Baseline hemoglobin > 16 g/dL
• Hematocrit 50%
• Poorly controlled blood pressure as defined by Systolic Blood Pressure (SBP) >150 or Diastolic Blood Pressure (DBP) > 90 on two separate measurements
• Concurrent use of any prohibited medications that can affect testosterone levels or metabolism.
• History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
• History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
• History of stroke or myocardial infarction within the past 5 years.
• History of, or current or suspected, prostate or breast cancer.
• History of, or current or suspected, pituitary abnormality.
• History of diagnosed, severe, untreated, obstructive sleep apnea.
• History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
• Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.
• Inability to understand and provide written informed consent for the study.
• Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Jatenzo