None listed
Conditions
Brief summary
Although intramuscular injections of androgen's are known to be effective, they result in varying degrees of pain at the injection site that may last for a day or two. These injections need to be given into a precise location of the buttocks and require staff with expert training. Unlike many other injections these cannot be self-injected due to the difficulty of safely injecting into the buttocks. A SC injection, if effective, may be given by yourself in your own home, which would be more convenient to avoid extra medical visits as well as saving GP and hospital resources. Many men who require androgen replacement therapy may have bleeding disorders or are on medications that may intentionally slow the ability of their blood to clot. These men have a theoretical risk of bleeding and a very large bruise deep in an important muscle may later become infected and cause significant disability. As a result men using these anti-clotting drugs are usually prescribed other forms of androgen replacement therapy that are not always optimal. A SC injection, if effective, may be used in these men. Nandrolone decanoate (ND) Subcutaneous (SC) will be trialed in healthy volunteers,with a historical, intramuscular (IM) control data set. This is the first stage of a 2 stage research study
Interventions
Nandrolone Decanoate (ND) 100 mg in 2 mL oil vehicle administered as a single subcutaneous injection under the abdominal skin.
Sponsors
Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: * Healthy male volunteers * Aged 18-55 yr * Written, informed consent & willing to comply with study requirements
Exclusion criteria
* Contraindication to nanadrolone * Seeking fertility in the next year * Involved in any professional or recreational activities requiring urine drug screening * History of illicit drug abuse within last year * History of major psychiatric disease or psychological condition that may limit understanding and compliance with study requirements * Regular medications that interfere with absorption, metabolism or action of testosterone * Taking medications for antiplatelet or anticoagulant therapy
Outcome results
None listed