HypotestosteronismEarly Phase 1TestoSupNCT07143279
Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life
A Early Phase 1 study testing Sustanon 250 in people with Hypotestosteronism and Palliative Care, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypotestosteronism, Palliative Care
- What is being tested?
- Sustanon 250
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Feb 2026to Nov 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age ≥ 18 years old
- Patient able to understand the patient information sheet and able to sign the Informed Consent form (ICF) prior to any study related procedure.
Who cannot join
- Untreated prostate cancer, given the risk of epiduritis.
- Known hypersensitivity reactions to the study drug or to any excipients.
- Known allergies to peanuts or soya.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1070
Isabelle Libert, MD, +32 (0)2 541 39 92, isabelle.libert@hubruxelles.be
Isabelle Libert, MD
About this study
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.
- Conditions
- Hypotestosteronism, Palliative Care
- Being tested
- Sustanon 250
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustanon 250Drug
Also called Testosterone
Sustanon 250® (1 ml, IM) every 10 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sustanon 250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Every 15 days through study completion,
Secondary outcomes (2)
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)
Measured: Every 15 days through study completion
Dynamic/change of the ADL and Edmonton System Assessment Scale during treatment
The average of ADL and Edmonton Symptom Assessment Scale during treatment after baseline.
Measured: At each time point during treatment, especially at Day 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start11 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotestosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143279
- Sponsor's protocol ID
- IJB-SP01-2025
- Other IDs
- 2025-522023-10-00, 2025
- Acronym
- TestoSup
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT07143279
- Acronym / sponsor ID
- TestoSup / IJB-SP01-2025
- Conditions
- Hypotestosteronism, Palliative Care
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testosterone supplementation in patients in best supportive care: impact on quality of life | Experimental | Drug: Sustanon 250Single-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- Age ≥ 18 years old
- Patient able to understand the patient information sheet and able to sign the Informed Consent form (ICF) prior to any study related procedure.
Key exclusion criteria (3 listed)
- Untreated prostate cancer, given the risk of epiduritis.
- Known hypersensitivity reactions to the study drug or to any excipients.
- Known allergies to peanuts or soya.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustanon 250Also: TestosteroneSustanon 250® (1 ml, IM) every 10 days | Drug | Testosterone supplementation in patients in best supportive care: impact on quality of life |
Primary outcome
Quality of life assessed by ADL questionnaire
Time frame: Every 15 days through study completion
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.
Quality of life assessed by Edmonton Symptom Assessment Scale
Time frame: Every 15 days through study completion,
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.
2 secondary outcomes
EQ-5D-3L questionnaire
Time frame: Every 15 days through study completion
Dynamic/change of the ADL and Edmonton System Assessment Scale during treatment
Time frame: At each time point during treatment, especially at Day 15.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sustanon 250 in people with Hypotestosteronism and Palliative Care, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessed by ADL questionnaire (time frame: Every 15 days through study completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.