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

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.

Study Overview

• Status: Completed
• Conditions: Transgender Persons; Health Services for Transgender Persons
• Intervention / Treatment: Drug: Testosterone injection; Behavioral: PedsQL questionnarie; Other: Masculinizing effects questionnaire; Other: Medication experience questionnaire

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Transgender males who have received testosterone therapy in the past

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized SQ vs IM; Subjects randomized to either SQ or IM testosterone injections follow study protocol.	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.
Experimental: Non-randomized SQ; Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.	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.
Experimental: Non-randomized IM; Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum testosterone level	Trough and peak serum testosterone level	Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Kara Connelly, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Gender affirming care
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: STUDY00017454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No