Testosterone propionate

Table of contents

• What is testosterone propionate?
• How does testosterone propionate work?
• Which conditions is it used or studied for?
• How is testosterone propionate given?
• What do the clinical trials show?
• What side effects are known?

What is testosterone propionate?

Testosterone propionate is a synthetic form of the male sex hormone testosterone. It belongs to a class of medicines called androgens, which are responsible for the development and maintenance of male characteristics.^[2] In the clinical trial registry, the substance is recorded as a combination of four testosterone esters: testosterone decanoate, testosterone isocaproate, testosterone phenylpropionate, and testosterone propionate.^[1] These four esters together form the authorised medicine Sustanon 250, a solution for injection.^[1] Testosterone propionate is already authorised as a medicine, with a marketing authorisation record in Belgium (BE012704).^[1] The authorisation holder is Aspen Pharma Trading Limited.^[1] Other testosterone-containing products authorised in Europe include gels such as Testogel, Androgel and Tostran, oral capsules such as Andriol Testocaps, and the long-acting injection Nebido (testosterone undecanoate).^[5]

How does testosterone propionate work?

Testosterone is the main male sex hormone. In men who do not produce enough testosterone — a condition known as hypogonadism — replacing the missing hormone helps restore normal levels in the body.^[2] Testosterone acts on androgen receptors in many tissues, influencing muscle mass, bone density, red blood cell production, mood, energy and sexual function. In the palliative care setting studied in the registered trial, the hypothesis is that restoring testosterone levels may improve symptoms such as fatigue, reduced appetite, low mood and loss of independence in daily activities.^[1] The exact mechanism by which testosterone might improve quality of life in patients with advanced cancer is still being investigated.

Which conditions is it used or studied for?

• Hypogonadism — a condition in which men do not produce enough testosterone. Testosterone-containing medicines are authorised in several EU countries to replace the missing hormone.^[2]
• Androgen deficiency — this is the condition named in the registered trial, referring to low levels of male sex hormones in men with advanced disease.^[1]
• Palliative care — the trial is studying men in best supportive care who have no therapeutic options left and do not wish to be resuscitated.^[1]
• Menopausal symptoms in women — testosterone can also be used in women, in combination with oestrogens, for the management of menopausal symptoms.^[2]

How is testosterone propionate given?

The registered trial uses Sustanon 250, a solution for injection. In the trial record, the route of administration is listed as intravenous use.^[1] In routine clinical practice, testosterone is available in several different forms. These include transdermal gels applied to the skin, such as Testogel, Androgel, Tostran and Testavan, oral capsules such as Andriol Testocaps, and intramuscular injections such as Nebido.^[5][4] The Bradford Teaching Hospitals formulary lists Sustanon 250 as a formulary injection for testosterone replacement.^[3]

What do the clinical trials show?

One registered clinical trial is investigating testosterone propionate as part of Sustanon 250. The trial is a Phase 2 interventional study with a planned enrolment of 25 male participants.^[1] It is currently authorised but has not yet started recruiting.^[1]

Who can take part in this trial?

The trial is open to male patients in best supportive care who have no therapeutic options left and who do not wish to be resuscitated.^[1] These are patients with advanced disease, in this case recorded under the therapeutic area of neoplasms (cancers), who are receiving palliative care focused on quality of life rather than cure.^[1]

What is the trial measuring?

The trial has two primary outcome measures. The first is the best improvement over time in independence, measured using the ADL independence scale. This scale covers personal hygiene, dressing, going to the toilet, locomotion, continence and eating.^[1] The second is the best improvement over time in symptoms, measured using the Edmonton Symptom Assessment Scale. This covers pain, fatigue, sadness, anxiety, drowsiness, appetite, sense of well-being, shortness of breath, bowel movements and strength.^[1] The overall aim is to evaluate the impact of testosterone supplementation on the quality of life of male patients in best supportive care.^[1]

What side effects are known?

A safety review by the European Medicines Agency was started in 2013 because of concerns about the effects of testosterone on the heart.^[2] Studies suggested that the use of testosterone may increase the risk of myocardial infarction (heart attack) in men aged over 65 years, as well as in younger men with pre-existing heart disease.^[2] Another study, the Veterans Health Care Study, suggested that men with pre-existing heart disease who received testosterone had a higher risk of heart problems than men who did not receive testosterone.^[2] The review covered all testosterone-containing medicines authorised in the EU, in men and women, and assessed whether their marketing authorisations should be maintained, varied, suspended or withdrawn.^[2]