Patient Satisfaction After Switching to Oral Testosterone Undecanoate
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Jatenzo Arm Participants in this group will receive Jatenzo for 26 consecutive weeks. |
Drug: Jatenzo
237 mg soft gel capsule taken twice a day by mouth with food.
|
Outcome Measures
Primary Outcome Measures
- Change in patient satisfaction as measured by TSQM-9 [Baseline to 3 months, Baseline to 6 months]
Treatment Satisfaction Questionnaire for Medication (TSQM-9) has a total score ranging from 8 to 53 with the higher score indicating higher patient satisfaction
- Change in low testosterone symptoms as measured by qADAM questionnaire [Baseline to 3 months, Baseline to 6 months]
Quantitative Androgen Deficiency in the Aging Male (qADAM) has a total score ranges between 10 (most symptomatic) and 50 (least symptomatic)
Secondary Outcome Measures
- Change in testosterone levels [Baseline to 3 months, Baseline to 6 months]
Testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw
- Change in estrogen levels [Baseline to 3 months, Baseline to 6 months]
Estrogen levels measured in pg/mL analyzed from peripheral venous puncture blood draw
- Change in hematocrit levels [Baseline to 3 months, Baseline to 6 months]
Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw
- Change in PSA levels [Baseline to 3 months, Baseline to 6 months]
Prostate Specific Antigen (PSA) levels measured in ng/mL analyzed from peripheral venous puncture blood draw
- Number of participants reporting preference with the use of Jatenzo [6 months]
Number of participants responding 'yes' to a single question self-reported survey asking if the use of Jatenzo is preferred compared to prior testosterone therapy
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Males between 18 and 65 years of age.
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Documented diagnosis of testosterone deficiency.
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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).
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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:
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History of significant sensitivity or allergy to androgens or product excipients.
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Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up or abnormal ECG.
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Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score > 19 points.
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Body mass index (BMI) ≥ 40 kg/m2.
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Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
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Baseline hemoglobin > 16 g/dL
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Hematocrit < 35% or > 50%
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Poorly controlled blood pressure as defined by Systolic Blood Pressure (SBP) >150 or Diastolic Blood Pressure (DBP) > 90 on two separate measurements
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Concurrent use of any prohibited medications that can affect testosterone levels or metabolism.
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History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
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History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
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History of stroke or myocardial infarction within the past 5 years.
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History of, or current or suspected, prostate or breast cancer.
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History of, or current or suspected, pituitary abnormality.
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History of diagnosed, severe, untreated, obstructive sleep apnea.
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History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
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Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.
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Inability to understand and provide written informed consent for the study.
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Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Jatenzo
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
- Clarus Therapeutics
Investigators
- Principal Investigator: Ranjith Ramasamy, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20200971