NCT03864913

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 14 Years – 19 Years
• Healthy volunteers: Accepted

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.

Conditions

• Health Services for Transgender Persons
• Transgender Persons

Interventions

Type	Name	Description
DRUG	Testosterone injection	SQ or IM testosterone injections for pubertal induction of transgender male adolescents. Increasing doses per protocol at 3 month and 6 month follow up.
BEHAVIORAL	PedsQL questionnarie	Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.
OTHER	Masculinizing effects questionnaire	Subjects complete self-reported questionnaire at 3 month and 6 month study visits.
OTHER	Medication experience questionnaire	Subjects complete self-reported questionnaire at 3 month and 6 month study visits.

Timeline

• Start date: 2018-01-26
• Primary completion: 2019-06-30
• Completion: 2019-12-30
• First posted: 2019-03-06
• Last updated: 2024-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study