CompletedPhase 4ACTRN12613000101785

A Research Study of Injections of Testosterone in an Oil Vehicle for men with Androgen Deficiency: Reandron (Testosterone Undecanoate) will be administered subcutaneously and intramuscularly.

Pharmacokinetics of Subcutaneous Injection of Testosterone in an Oil Vehicle: A Randomised crossover study of Reandron (Testosterone Undecanoate) given subcutaneously and intramuscularly in hypogonadal men.


Sponsor

Sydney Local Health District

Enrollment

12 participants

Start Date

Feb 12, 2014

Study Type

Interventional

Conditions

Summary

Although intramuscular (IM) 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 subcutaneous (SC) injection, if effective, may be used in these men. This is a randomised crossover study of testosterone Undecanoate given subcutaneously and intramuscularly in patients receiving testosterone replacement therapy. Each participant will receive a single IM injection and a single (SC) injection of TU. An IM injection is standard of care and duration of action is approximately 12 weeks. It is expected a SC injection will have a duration of action of 12 weeks. Thus the study will take 24 weeks for each participant to complete both arms. This is the second stage of a 2 stage research study. This is stage 2 of study ACTRN12613000068763


Eligibility

Sex: MalesMin Age: 18 Yearss

Inclusion Criteria2

  • Already receiving regular testosterone treatment.
  • Written, informed consent & willing to comply with study requirements

Exclusion Criteria4

  • Contraindication to testosterone
  • 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 which may require dosage change during the study
  • Taking medications for antiplatelet or anticoagulant therapy

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Interventions

Testosterone Undecanoate (TU) 1000mgs in 4 mL oil vehicle. Arm 1, Administered as a single subcutaneous (SC) injection under the abdominal skin. Arm 2, Administered as a single intramuscular (IM

Testosterone Undecanoate (TU) 1000mgs in 4 mL oil vehicle. Arm 1, Administered as a single subcutaneous (SC) injection under the abdominal skin. Arm 2, Administered as a single intramuscular (IM) injection into the buttock. Participants will be randomised to one of the two arms. Then after 12 weeks will receive treatment in the second arm.


Locations(1)

Concord Repatriation Hospital - Concord

NSW, Australia

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ACTRN12613000101785