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

NCT03864913 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-04-03

No results posted yet for this study

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.

Conditions

  • Health Services for Transgender Persons
  • Transgender Persons

Interventions

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.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Kara Connelly, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-26
Primary Completion
2019-06-30
Completion
2019-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03864913 on ClinicalTrials.gov