Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents

Objectives:

1. Determine the efficacy of SQ testosterone compared to IM testosterone therapy.
Hypothesis: SQ testosterone is equally efficacious to IM testosterone in achieving
mid-pubertal testosterone levels and masculinizing physical changes in transgender male
adolescents after 6 months.

2. Determine the rate of adverse reactions of SQ and IM testosterone during the first 6
months of treatment.

Hypothesis: SQ testosterone results in equal or fewer adverse reactions than IM
testosterone.

3. Evaluate quality of life (QOL) and satisfaction of injection technique for SQ and IM
testosterone.

Hypothesis: Subjects receiving SQ testosterone will report equal or superior quality of
life and satisfaction with injection technique compared to IM testosterone as SQ is less
painful and easier to administer at home.

4. Evaluate and compare the number of clinical visits required for testosterone injections
by transgender male patients receiving SQ and IM therapy.

Hypothesis: Subjects using SQ testosterone will have fewer clinic visits than those using IM
testosterone. This may impact healthcare-related costs.

Study Outline:

6 month study consisting of three study visits at baseline, 3 months and 6 months. Optional
cross over of injection modality from 6-9 months. At each visit subjects complete blood work
and questionnaires to determine testosterone peak and trough levels as well as biochemical
adverse effects, quality of life, masculinizing effects and medication experience.

Inclusion Criteria:

- Testosterone naive

- Transgender male

- 14-19 years old

Exclusion Criteria:

- Transgender males who have received testosterone therapy in the past