The trial studies the efficacy of subcutaneous (SQ) testosterone compared to intramuscular (IM) testosterone therapy during the first 6 months of pubertal induction in transgender male adolescents. Describes rate of adverse effects, masculinizing effects and quality of life while receiving testosterone. Evaluates clinic utilization required for testosterone therapy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
SQ or IM testosterone injections for pubertal induction of transgender male adolescents. Increasing doses per protocol at 3 month and 6 month follow up.
Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.
Subjects complete self-reported questionnaire at 3 month and 6 month study visits.
Oregon Health and Science University
Portland, Oregon, United States
Serum testosterone level
Trough and peak serum testosterone level
Time frame: Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up
Rate of adverse effects
Time frame: Assessed at 3 month and 6 month follow up
PedsQL questionnaire score
Validated pediatric quality of life tool
Time frame: Completed at baseline, 3 month and 6 month follow up
Masculinizing effects
Self reported, questionnaire
Time frame: Completed at 3 month and 6 month follow up
Medication experience
Self reported, questionnaire
Time frame: Completed at 3 month and 6 month follow up
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Subjects complete self-reported questionnaire at 3 month and 6 month study visits.