CompletedPhase 4

Patient Satisfaction After Switching to Oral Testosterone Undecanoate

United States41 participantsStarted 2021-06-18

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexMALE

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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 \< 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).
✓. 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

✕. History of significant sensitivity or allergy to androgens or product excipients.
✕. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up or abnormal ECG.
✕. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score \> 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 \< 35% or \> 50%
✕. Poorly controlled blood pressure as defined by Systolic Blood Pressure (SBP) \>150 or Diastolic Blood Pressure (DBP) \> 90 on two separate measurements

What they're measuring

Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain)

Timeframe: Up to 6 months

Hypogonadal Symptoms as Measured by qADAM Questionnaire

Timeframe: Up to 6 months

Trial details

NCT IDNCT04983940

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-06

Results submitted2023-11-21

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