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Hormone Therapy

Non-randomized IM for Health Services for Transgender Persons

Phase < 1
Waitlist Available
Led By Kara Connelly, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Testosterone naive
Transgender male
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 3 month and 6 month follow up
Awards & highlights

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.

Eligible Conditions
  • Health Services for Transgender Persons
  • Transgender

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serum testosterone level
Secondary outcome measures
Masculinizing effects
Medication experience
PedsQL questionnaire score
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Randomized SQ vs IMExperimental Treatment4 Interventions
Subjects randomized to either SQ or IM testosterone injections follow study protocol.
Group II: Non-randomized SQExperimental Treatment4 Interventions
Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.
Group III: Non-randomized IMExperimental Treatment4 Interventions
Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone
FDA approved
PedsQL questionnarie
2018
Completed Early Phase 1
~30

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
6,846,003 Total Patients Enrolled
Kara Connelly, MDPrincipal InvestigatorOregon Health and Science University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents
Kara Connelly 2018. "Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03864913.
~4 spots leftby Apr 2025
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