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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized SQ vs IM | Experimental | Subjects randomized to either SQ or IM testosterone injections follow study protocol. |
|
| Non-randomized SQ | Experimental | Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol. |
|
| Non-randomized IM | Experimental | Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone injection | Drug | SQ or IM testosterone injections for pubertal induction of transgender male adolescents. Increasing doses per protocol at 3 month and 6 month follow up. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Transgender male
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| Name | Affiliation | Role |
|---|---|---|
| Kara Connelly, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
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Randomized arm (SQ, IM), as well as non-randomized SQ and non-randomized IM.
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| PedsQL questionnarie | Behavioral | Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits. |
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| Masculinizing effects questionnaire | Other | Subjects complete self-reported questionnaire at 3 month and 6 month study visits. |
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| Medication experience questionnaire | Other | Subjects complete self-reported questionnaire at 3 month and 6 month study visits. |
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| 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 |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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