Clinical trial NCT03864913: Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents
Official title: Investigating the Efficacy of Subcutaneous Testosterone Compared to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Health Services for Transgender Persons
Transgender Persons
Keywords: Gender affirming care
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 26
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized arm (SQ, IM), as well as non-randomized SQ and non-randomized IM.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Testosterone naive
* Transgender male
* 14-19 years old

Exclusion Criteria:

* Transgender males who have received testosterone therapy in the past

Primary outcomes:
measure: Serum testosterone level
timeFrame: Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Assessed at 3 month and 6 month follow up
measure: PedsQL questionnaire score
timeFrame: Completed at baseline, 3 month and 6 month follow up
measure: Masculinizing effects
timeFrame: Completed at 3 month and 6 month follow up
measure: Medication experience
timeFrame: Completed at 3 month and 6 month follow up
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kara Connelly, MD
role: PRINCIPAL_INVESTIGATOR
References: