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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03864913
Other study ID # STUDY00017454
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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