Investigating the Efficacy of Subcutaneous Testosterone Compared to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Serum testosterone level
Study Overview
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:
- 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. 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 19 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Testosterone naive
- •Transgender male
- •14-19 years old
Exclusion Criteria
- •Transgender males who have received testosterone therapy in the past
Arms & Interventions
Randomized SQ vs IM
Subjects randomized to either SQ or IM testosterone injections follow study protocol.
Intervention: Testosterone injection (Drug)
Randomized SQ vs IM
Subjects randomized to either SQ or IM testosterone injections follow study protocol.
Intervention: PedsQL questionnarie (Behavioral)
Randomized SQ vs IM
Subjects randomized to either SQ or IM testosterone injections follow study protocol.
Intervention: Masculinizing effects questionnaire (Other)
Randomized SQ vs IM
Subjects randomized to either SQ or IM testosterone injections follow study protocol.
Intervention: Medication experience questionnaire (Other)
Non-randomized SQ
Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.
Intervention: Testosterone injection (Drug)
Non-randomized SQ
Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.
Intervention: PedsQL questionnarie (Behavioral)
Non-randomized SQ
Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.
Intervention: Masculinizing effects questionnaire (Other)
Non-randomized SQ
Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.
Intervention: Medication experience questionnaire (Other)
Non-randomized IM
Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.
Intervention: Testosterone injection (Drug)
Non-randomized IM
Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.
Intervention: PedsQL questionnarie (Behavioral)
Non-randomized IM
Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.
Intervention: Masculinizing effects questionnaire (Other)
Non-randomized IM
Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.
Intervention: Medication experience questionnaire (Other)
Outcomes
Primary Outcomes
Serum testosterone level
Time Frame: Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up
Trough and peak serum testosterone level
Secondary Outcomes
- Rate of adverse effects(Assessed at 3 month and 6 month follow up)
- Masculinizing effects(Completed at 3 month and 6 month follow up)
- PedsQL questionnaire score(Completed at baseline, 3 month and 6 month follow up)
- Medication experience(Completed at 3 month and 6 month follow up)
Investigators
Kara Connelly
Principal Investigator
Oregon Health and Science University