In short
Testosterone cipionate is a synthetic form of the male hormone testosterone, classified as a chemical substance and authorised as a medicine. In the EU Clinical Trials Information System (CTIS), it appears as a test substance in one Phase 2 trial for paraphilic disorder and compulsive sexual behavior disorder. This trial, PREVENT-MED, plans to enroll 180 participants and is currently authorised.
Testosterone cipionate is a synthetic form of the male sex hormone testosterone. It is a chemically synthesised substance and is authorised as a medicine. In the CTIS registry, it is classified under the therapeutic area of psychiatry and psychology, specifically mental disorders. The substance is also known simply as testosterone, and its ATC code is G03BA03.
The table of contents below lists the questions this page answers about testosterone cipionate and its clinical research.
Key points
- Testosterone cipionate is a synthetic form of the male hormone testosterone, authorised as a medicine.
- It is being studied in a Phase 2 trial for paraphilic disorder and compulsive sexual behavior disorder.
- The trial compares cognitive behavioral therapy alone versus therapy combined with testosterone suppression.
- The planned enrollment is 180 participants across the study.
- The trial is currently authorised but not yet recruiting.
- Testosterone cipionate is given by injection as a sterile solution.
What is testosterone cipionate?
Testosterone cipionate is a synthetic, chemically produced form of the naturally occurring male hormone testosterone. It is an authorised medicine, meaning it has received marketing approval for use in patients. The product name under which it appears in the registry is simply "testosterone". Testosterone cipionate is also sold under the brand name AZMIRO as an injectable solution, according to product labelling.
How does testosterone cipionate work?
Testosterone is the primary male sex hormone, and testosterone cipionate acts as a replacement or supplement to the body's own testosterone. The exact exposure-response relationship for testosterone's safety and effectiveness has not been fully characterised, according to the product label. In the PREVENT-MED trial, testosterone is not being studied for its androgenic effects alone; rather, it is used as an add-back treatment at minimal or low doses in combination with degarelix, a drug that suppresses testosterone production.
Which conditions is it used or studied for?
- Paraphilic disorder — a condition involving intense and persistent sexual interests that cause distress or harm, studied in the PREVENT-MED trial.
- Compulsive sexual behavior disorder — a condition characterised by a persistent pattern of failure to control intense, repetitive sexual impulses, also studied in the PREVENT-MED trial.
How is testosterone cipionate given?
Testosterone cipionate is available as an injectable solution. The product AZMIRO is supplied as a sterile, clear colourless to pale yellow solution in single-dose vials and prefilled syringes at a concentration of 200 mg/mL. In the PREVENT-MED trial, the intervention involving testosterone is described as a 20 mg dose for cutaneous use (applied to the skin), although the substance data also lists the route of administration as cutaneous use. Subcutaneous injection of testosterone has been described as a safe, practical, and reasonable option in clinical literature.
What do the clinical trials show?
There is one registered clinical trial for testosterone cipionate in the CTIS database: PREVENT-MED (EU CT number 2024-518120-68-01). It is a Phase 2 interventional study with a planned enrollment of 180 participants. The trial is currently in the "Authorised" status, meaning it has received regulatory approval to proceed but has not yet started recruiting.
The trial compares two approaches: cognitive behavioral therapy (CBT) alone versus CBT combined with testosterone suppression using degarelix, with testosterone added back at minimal or low doses. The primary outcome is the total score on the Sexual Offender Treatment Progress Scale (SOTIPS), measured at baseline and at 30, 180, and 365 days after randomisation. A second primary outcome assesses whether add-back treatment with minimal or low dose testosterone is non-inferior for the risk of committing sexual abuse.
What side effects are known?
According to the AZMIRO product label, serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, including cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, and hepatotoxicity. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth, potentially compromising final adult height. Precocious puberty has also been reported with testosterone use. Testosterone is a Schedule III controlled substance, with abuse and misuse reported in male and female adults and adolescents.