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 range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Testosterone Deficiency trials