Health Services for Transgender Persons, Transgender Persons
Conditions
Keywords
Gender affirming care
Brief summary
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.
Detailed description
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.
Interventions
SQ or IM testosterone injections for pubertal induction of transgender male adolescents. Increasing doses per protocol at 3 month and 6 month follow up.
BEHAVIORALPedsQL questionnarie
Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.
OTHERMasculinizing effects questionnaire
Subjects complete self-reported questionnaire at 3 month and 6 month study visits.
OTHERMedication experience questionnaire
Subjects complete self-reported questionnaire at 3 month and 6 month study visits.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized arm (SQ, IM), as well as non-randomized SQ and non-randomized IM.
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Testosterone naive * Transgender male * 14-19 years old
Exclusion criteria
* Transgender males who have received testosterone therapy in the past
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum testosterone level | Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up | Trough and peak serum testosterone level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse effects | Assessed at 3 month and 6 month follow up | — |
| PedsQL questionnaire score | Completed at baseline, 3 month and 6 month follow up | Validated pediatric quality of life tool |
| Masculinizing effects | Completed at 3 month and 6 month follow up | Self reported, questionnaire |
| Medication experience | Completed at 3 month and 6 month follow up | Self reported, questionnaire |
Countries
United States
Outcome results
None listed