Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents
NCT ID: NCT03864913
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
26 participants
INTERVENTIONAL
2018-01-26
2019-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Randomized SQ vs IM
Subjects randomized to either SQ or IM testosterone injections follow study protocol.
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.
PedsQL questionnarie
Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.
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.
Non-randomized SQ
Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.
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.
PedsQL questionnarie
Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.
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.
Non-randomized IM
Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.
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.
PedsQL questionnarie
Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.
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.
Interventions
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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.
PedsQL questionnarie
Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.
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.
Eligibility Criteria
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Inclusion Criteria
* Transgender male
* 14-19 years old
Exclusion Criteria
14 Years
19 Years
FEMALE
Yes
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Kara Connelly
Principal Investigator
Principal Investigators
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Kara Connelly, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health and Science University
Portland, Oregon, United States
Countries
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Other Identifiers
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STUDY00017454
Identifier Type: -
Identifier Source: org_study_id
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