Subcutaneous Testosterone Project

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

For people who identify as transgender, there is a strong sense that they were born into the wrong body and that their outward looking body does not match how they truly feel about themselves. They feel male, not female and have always felt that way. There is a great deal of discomfort or dysphoria about looking and feeling female, and there is a strong desire to achieve a more masculine appearance. While surgery, clothing and hair for example, can help a person appear more like a male, many transgender males will want to take testosterone to make them feel and look more masculine.

This usually involves injecting testosterone into a muscle every 1-2 weeks for many years. Intramuscular injections can often be uncomfortable or painful, and requires the patient to be taught how to inject themselves. Or somebody else has to do it. There is a growing trend in some transgender men to give their injection just below the skin or subcutaneously (like insulin in a diabetic), because it is less uncomfortable but we don't really know if testosterone gets into the blood in the same way. At least one clinic in the US already suggests that patients can use the subcutaneous method but there is almost no research to show it's the same as intramuscular.

Our project will be looking at a small group of transgender males who are already on intramuscular testosterone and then switch them over to the same dose of subcutaneous testosterone, and then compare their levels of testosterone. If those levels are similar, then patients may chose the less uncomfortable subcutaneous injection.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Vancouver Coastal Health Research Institute
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Transgender males or identifying along the male spectrum

• Currently on stable doses of weekly IM testosterone

• Using either Testosterone cypionate or enanthate

• Between 19-59 years old

• Stable doses of regular medications

• Receive their transgender care from one of five(5) Vancouver-based physicians who specialize in transgender care (Three Bridges or Raven Song Community Health Centres).

Exclusion Criteria:

• Medically or psychiatrically unstable

• Recent or imminent surgery (6-8 weeks) that has or may affect testosterone dosage

• Unable to present for nine(9) weeks of weekly blood work and two(2) weeks of alternate day blood work