Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life

NCT07143279 | Recruiting Early Phase 1

• 2 other identifiers: IJB-SP01-20252025-522023-10-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotestosteronism; Palliative Care

Outcome Measures

Primary Outcomes (2)

• 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,

Secondary Outcomes (2)

• EQ-5D-3L questionnaire

  Every 15 days through study completion

• Dynamic/change of the ADL and Edmonton System Assessment Scale during treatment

  At each time point during treatment, especially at Day 15.

Study Arms (1)

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.

Drug: Sustanon 250

Interventions

Sustanon 250 DRUG

Sustanon 250® (1 ml, IM) every 10 days

Also known as: Testosterone

Testosterone supplementation in patients in best supportive care: impact on quality of life

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Interventions

Testosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 27, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

BE (1)