Clinical Trial: Subcutaneous Testosterone Project
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Study of Subcutaneous vs. Intramuscular Testosterone for Gender Affirming Therapy
Brief 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.
Detailed Summary:
Rationale:
In caring for transgender males (born female but identify as male), intramuscular (IM) testosterone is considered standard of care if they elect therapy to transition. Yet, IM testosterone has limitations: discomfort; a modest amount of teaching; bleeding concerns if the patient is on anticoagulants; and fluctuations in circulating serum testosterone. Erratic absorption may also led to variability in mood and energy. Due to these limitations, there is a trend, especially in younger patients, to use the more comfortable subcutaneous (SC) route. However, there are little data suggesting equivalency of SC to IM testosterone and virtually no data in transgender males.
Hypothesis:
In transgender males, SC testosterone will yield similar pharmacokinetics and better tolerability when compared to IM testosterone.
Objectives:
- To validate, using a cross-over design, whether pharmacokinetic parameters of SC vs. IM testosterone administration are similar.
- To characterize, using a validated pain questionnaire and patient diary, tolerability of SC vs. IM testosterone.
Research Plan:
Patients (19-59 years old) on a weekly self-injection schedule of either T cypionate or enanthate will be included. Patients with medical instability, recent or imminent surgery will be excluded. Twenty-five patients will be recruited from the 6 local Vancouver Coastal HealthTrans Primary Care physicians' clinics.
Using a cross-over design, trough serum testosterone levels from th
Sponsor: University of British Columbia
Current Primary Outcome: Serum Testosterone (Total) [ Time Frame: 11 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Pharmacokinetics of serum testosterone [ Time Frame: 2 weeks ]
Original Secondary Outcome: Same as current
Information By: University of British Columbia
Dates:
Date Received: August 28, 2014
Date Started: July 2015
Date Completion:
Last Updated: June 2, 2016
Last Verified: June 2016
