A Pilot Study of Subcutaneous vs. Intramuscular Testosterone for Gender Affirming Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Serum Testosterone (Total)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Injectable testosterone
We will take a group of transgender males, already on a stable dosage of intramuscular testosterone, and then using their same type and dosage, switch them to the subcutaneous injection route. Weekly trough (just before their weekly injection) levels of total serum testosterone will be taken to compare the steady states of those two injection routes.
干预措施: Subcutaneous testosterone (Drug)
结局指标
主要结局
Serum Testosterone (Total)
时间窗: 11 weeks
To compare the steady state levels of total serum testosterone using the Subcutaneous (SC) and Intramuscular (IM) injection routes in a group of transgender males who are already on stable IM dosages.
次要结局
- Pharmacokinetics of serum testosterone(2 weeks)