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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522023-10-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone supplementation in patients in best supportive care: impact on quality of life | Experimental | 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. Administration of Sustanon 250® (1 ml, IM) on day 0 after confirmation of hypogonadism by blood test and then every 15 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustanon 250 | Drug | Sustanon 250® (1 ml, IM) every 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessed by ADL questionnaire | Best improvement over time in independence using the ADL independence scale in terms of personal hygiene, dressing, going to the toilet, locomotion, continence and eating. The primary endpoint is defined as the difference between the best score after baseline and the initial score at baseline. | Every 15 days through study completion |
| Quality of life assessed by Edmonton Symptom Assessment Scale | Best improvement over time in symptoms of pain, fatigue, sadness, anxiety, drowsiness, appetite, sense of well-being, shortness of breath, bowel movements and strength using the Edmonton Symptom Assessment Scale. The primary endpoint is defined as the difference between the best score after baseline and the initial score at baseline. | Every 15 days through study completion, |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D-3L questionnaire | Improvement of quality of life of subjects from the point of view of a proxy using the EQ-5D-3L questionnaire (EQ-5D-3L scale 0-100 where 0=worst outcome and 100=better outcome) | Every 15 days through study completion |
| Dynamic/change of the ADL and Edmonton System Assessment Scale during treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Recruiting | Brussels | 1070 | Belgium |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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The average of ADL and Edmonton Symptom Assessment Scale during treatment after baseline. |
| At each time point during treatment, especially at Day 15. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |