Patient Satisfaction After Switching to Oral Testosterone Undecanoate
Condition: Testosterone Deficiency
Intervention: Jatenzo
Intervention description: 237 mg soft gel capsule taken twice a day by mouth with food.
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to evaluate patient satisfaction with an oral
      testosterone agent, Jatenzo, compared to other forms of testosterone therapy.
    

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. Males between 18 and 65 years of age.

          3. Documented diagnosis of testosterone deficiency.

          4. Prior treatment with testosterone therapy at the time of enrollment with adequate
             control of low testosterone symptoms. Serum total testosterone < 300 ng/dL on 2
             measurements prior to the initiation of testosterone therapy. Patients must have
             completed an adequate washout period following prior testosterone therapy (4 weeks for
             gels and injection based therapies and 16 weeks for subcutaneous pellets).

          5. Judged to be in good general health as determined by the principal investigator based
             upon 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 or abnormal ECG.

          3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or
             International Prostate Symptom Score (I-PSS) score > 19 points.

          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

               2. Hematocrit < 35% or > 50%

          6. Poorly controlled blood pressure as defined by Systolic Blood Pressure (SBP) >150 or
             Diastolic Blood Pressure (DBP) > 90 on two separate measurements

          7. Concurrent use of any prohibited medications that can affect testosterone levels or
             metabolism.

          8. History of seizures or convulsions, including febrile, alcohol or drug withdrawal
             seizures.

          9. History of any clinically significant illness, infection, or surgical procedure within
             4 weeks prior to study drug administration.

         10. History of stroke or myocardial infarction within the past 5 years.

         11. History of, or current or suspected, prostate or breast cancer.

         12. History of, or current or suspected, pituitary abnormality.

         13. History of diagnosed, severe, untreated, obstructive sleep apnea.

         14. History of abuse of alcohol or any drug substance in the opinion of the investigator
             within the previous 2 years.

         15. Receipt of any investigational product within 4 weeks or within 5 half-lives prior to
             the start of treatment.

         16. Inability to understand and provide written informed consent for the study.

         17. Considered by the investigator or the sponsor-designated physician, for any reason,
             that the subject is an unsuitable candidate to receive Jatenzo