NCT07143279 Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life
| NCT ID | NCT07143279 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Jules Bordet Institute |
| Condition | Hypotestosteronism |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-02-11 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-02-11 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a monocentric, single-arm prospective pilot study that will enrol hypogonadal (testosterone \< 231 ng/dL) male subjects in best supportive care, with no further therapeutic options and no need for resuscitation. Currently, testosterone formulations for intramuscular (IM) injection and subcutaneous injection as well as for oral and transdermal administration have been approved for androgen therapy. To date, injectable testosterone is the most commonly used formulation. To increase serum testosterone levels to the physiological range IM injections of testosterone every 2-3 weeks are required, which lead to supraphysiological peaks shortly after administration, followed by a sharp fall in levels thereafter. Testosterone levels before the next injection are frequently in the hypogonadal range. For this reason, Sustanon 250® (1 ml, IM) will be administered on day 0 after confirmation of hypogonadism by blood test and then every 15 days in this trial given the limited life expectancy of the subjects and to maximise the effect and benefit of testosterone supplementation. The Edmonton questionnaire and ADL questionnaire will be completed before the injection on day 0 and then every 15 days at the time of injection until subject's death or if a subject is discontinued from the study treatment/procedures for any other reasons than death. In parallel, the EQ-5D-3L questionnaire will be completed by a family member or a proxy.
Eligibility Criteria
Inclusion Criteria: 1. Male hypogonadal with total testosterone \< 231 ng/dl in best supportive care with no further therapeutic options and who do not wish to be reanimated. 2. Age ≥ 18 years old 3. Patient able to understand the patient information sheet and able to sign the Informed Consent form (ICF) prior to any study related procedure. Exclusion Criteria: 1. Untreated prostate cancer, given the risk of epiduritis. 2. Known hypersensitivity reactions to the study drug or to any excipients. 3. Known allergies to peanuts or soya.
Frequently Asked Questions
Who can join the NCT07143279 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Hypotestosteronism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07143279 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07143279 currently recruiting?
Yes, NCT07143279 is actively recruiting participants. Visit ClinicalTrials.gov or contact Jules Bordet Institute to inquire about joining.
Where is the NCT07143279 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT07143279 clinical trial?
NCT07143279 is sponsored by Jules Bordet Institute. The trial plans to enroll 20 participants.