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

Transgender Persons Clinical Trial

Official title:

Investigating the Efficacy of Subcutaneous Testosterone Compared to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864913
• Other study ID #: STUDY00017454
• Status: Completed
• Phase: Early Phase 1
• Start date: January 26, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

Inclusion Criteria:

• Testosterone naive

• Transgender male

• 14-19 years old

Exclusion Criteria:

• Transgender males who have received testosterone therapy in the past

Related Conditions & MeSH terms

• Health Services for Transgender Persons
• Transgender Persons

Intervention

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.
• Medication experience questionnaire
Subjects complete self-reported questionnaire at 3 month and 6 month study visits.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of adverse effects		Assessed at 3 month and 6 month follow up
Secondary	PedsQL questionnaire score	Validated pediatric quality of life tool	Completed at baseline, 3 month and 6 month follow up
Secondary	Masculinizing effects	Self reported, questionnaire	Completed at 3 month and 6 month follow up
Secondary	Medication experience	Self reported, questionnaire	Completed at 3 month and 6 month follow up