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

Study Overview
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Brief Summary
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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
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Objectives: 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. 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. 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. 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.

Official Title
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Investigating the Efficacy of Subcutaneous Testosterone Compared to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents

Conditions
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Health Services for Transgender Persons, Transgender Persons

Intervention / Treatment
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* Drug: Testosterone injection
* Behavioral: PedsQL questionnarie
* Other: Masculinizing effects questionnaire
* Other: Medication experience questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Testosterone naive Transgender male 14-19 years old Exclusion Criteria: Transgender males who have received testosterone therapy in the past

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized arm (SQ, IM), as well as non-randomized SQ and non-randomized IM.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized SQ vs IM<br>Subjects randomized to either SQ or IM testosterone injections follow study protocol. | Drug: Testosterone injection<br>* SQ or IM testosterone injections for pubertal induction of transgender male adolescents. Increasing doses per protocol at 3 month and 6 month follow up.<br>Behavioral: PedsQL questionnarie<br>* Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.<br>Other: Masculinizing effects questionnaire<br>* Subjects complete self-reported questionnaire at 3 month and 6 month study visits.<br>Other: Medication experience questionnaire<br>* Subjects complete self-reported questionnaire at 3 month and 6 month study visits.<br>|
| Experimental: Non-randomized SQ<br>Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol. | Drug: Testosterone injection<br>* SQ or IM testosterone injections for pubertal induction of transgender male adolescents. Increasing doses per protocol at 3 month and 6 month follow up.<br>Behavioral: PedsQL questionnarie<br>* Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.<br>Other: Masculinizing effects questionnaire<br>* Subjects complete self-reported questionnaire at 3 month and 6 month study visits.<br>Other: Medication experience questionnaire<br>* Subjects complete self-reported questionnaire at 3 month and 6 month study visits.<br>|
| Experimental: Non-randomized IM<br>Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol. | Drug: Testosterone injection<br>* SQ or IM testosterone injections for pubertal induction of transgender male adolescents. Increasing doses per protocol at 3 month and 6 month follow up.<br>Behavioral: PedsQL questionnarie<br>* Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.<br>Other: Masculinizing effects questionnaire<br>* Subjects complete self-reported questionnaire at 3 month and 6 month study visits.<br>Other: Medication experience questionnaire<br>* Subjects complete self-reported questionnaire at 3 month and 6 month study visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum testosterone level | Trough and peak serum testosterone level | Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse effects |  | Assessed at 3 month and 6 month follow up | 
| PedsQL questionnaire score | Validated pediatric quality of life tool | Completed at baseline, 3 month and 6 month follow up | 
| Masculinizing effects | Self reported, questionnaire | Completed at 3 month and 6 month follow up | 
| Medication experience | Self reported, questionnaire | Completed at 3 month and 6 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gender affirming care