Recruiting EARLY_PHASE1 Hypotestosteronism

New treatment option for Hypotestosteronism

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

ClinicalTrials.gov ID: NCT07143279

What this study is testing

What is Sustanon 250?

Sustanon 250 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hypotestosteronism.

Also referred to as Testosterone.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, men only

You may be able to join 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...
  • 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 likely can't join 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Brussels, Belgium

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Brussels, Belgium. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.