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

Early Phase 1

Completed

• Conditions: Transgender Persons; Health Services for Transgender Persons
• Interventions: Drug: Testosterone injection; Behavioral: PedsQL questionnarie; Other: Masculinizing effects questionnaire; Other: Medication experience questionnaire

• Registration Number: NCT03864913
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study Start: 2018-01-26
• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

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

Exclusion Criteria

• Transgender males who have received testosterone therapy in the past

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-randomized IM	Testosterone injection	Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.
Randomized SQ vs IM	Medication experience questionnaire	Subjects randomized to either SQ or IM testosterone injections follow study protocol.
Non-randomized SQ	Testosterone injection	Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.
Randomized SQ vs IM	PedsQL questionnarie	Subjects randomized to either SQ or IM testosterone injections follow study protocol.
Randomized SQ vs IM	Masculinizing effects questionnaire	Subjects randomized to either SQ or IM testosterone injections follow study protocol.
Randomized SQ vs IM	Testosterone injection	Subjects randomized to either SQ or IM testosterone injections follow study protocol.
Non-randomized SQ	PedsQL questionnarie	Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.
Non-randomized SQ	Masculinizing effects questionnaire	Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.
Non-randomized IM	Medication experience questionnaire	Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.
Non-randomized SQ	Medication experience questionnaire	Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.
Non-randomized IM	PedsQL questionnarie	Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.
Non-randomized IM	Masculinizing effects questionnaire	Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.

Primary Outcome Measures

Name	Time	Method
Serum testosterone level	Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up	Trough and peak serum testosterone level

Secondary Outcome Measures

Name	Time	Method
Rate of adverse effects	Assessed at 3 month and 6 month follow up
Masculinizing effects	Completed at 3 month and 6 month follow up	Self reported, questionnaire
PedsQL questionnaire score	Completed at baseline, 3 month and 6 month follow up	Validated pediatric quality of life tool
Medication experience	Completed at 3 month and 6 month follow up	Self reported, questionnaire

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States