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

Oregon Health & Science University (OHSU)

Status and phase: Completed; Early Phase 1

Conditions: Health Services for Transgender Persons; Transgender Persons

Treatments: Other: Masculinizing effects questionnaire; Drug: Testosterone injection; Other: Medication experience questionnaire; Behavioral: PedsQL questionnarie

Study type: Interventional

Funder types: Other

Identifiers

NCT03864913

STUDY00017454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 14 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Transgender males who have received testosterone therapy in the past

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Randomized SQ vs IM

Experimental group

Description:

Subjects randomized to either SQ or IM testosterone injections follow study protocol.

Treatment:

Other: Medication experience questionnaire

Other: Masculinizing effects questionnaire

Behavioral: PedsQL questionnarie

Drug: Testosterone injection

Non-randomized SQ

Experimental group

Description:

Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.

Treatment:

Other: Medication experience questionnaire

Other: Masculinizing effects questionnaire

Behavioral: PedsQL questionnarie

Drug: Testosterone injection

Non-randomized IM

Experimental group

Description:

Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.

Treatment:

Other: Medication experience questionnaire

Other: Masculinizing effects questionnaire

Behavioral: PedsQL questionnarie

Drug: Testosterone injection