Health Services for Transgender PersonsEarly Phase 1NCT03864913
Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents
A Early Phase 1 study testing Testosterone injection, PedsQL questionnarie and Masculinizing effects questionnaire in people with Health Services for Transgender Persons and Transgender Persons, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Services for Transgender Persons, Transgender Persons
- What is being tested?
- Testosterone injection, PedsQL questionnarie and Masculinizing effects questionnaire
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2018to 30 Dec 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Testosterone naive
- Transgender male
- 14-19 years old
Who cannot join
- Transgender males who have received testosterone therapy in the past
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Investigating the Efficacy of Subcutaneous Testosterone Compared to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents
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.
Read the detailed description
Objectives:
- 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.
- 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.
- 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.
- 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.
- Being tested
- Testosterone injection, PedsQL questionnarie, Masculinizing effects questionnaire, Medication experience questionnaire
- Keywords
- Gender affirming care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone injectionDrug
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 questionnarieBehavioural
Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.
Masculinizing effects questionnaireOther
Subjects complete self-reported questionnaire at 3 month and 6 month study visits.
Medication experience questionnaireOther
Subjects complete self-reported questionnaire at 3 month and 6 month study visits.
| Study group | Role | What they receive |
|---|---|---|
| Randomized SQ vs IM | Experimental | Subjects randomized to either SQ or IM testosterone injections follow study protocol. Receives: Drug: Testosterone injection; Behavioral: PedsQL questionnarie; Other: Masculinizing effects questionnaire; Other: Medication experience questionnaire |
| Non-randomized SQ | Experimental | Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol. Receives: Drug: Testosterone injection; Behavioral: PedsQL questionnarie; Other: Masculinizing effects questionnaire; Other: Medication experience questionnaire |
| Non-randomized IM | Experimental | Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol. Receives: Drug: Testosterone injection; Behavioral: PedsQL questionnarie; Other: Masculinizing effects questionnaire; Other: Medication experience questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum testosterone level
Trough and peak serum testosterone level
Measured: Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up
Secondary outcomes (4)
Rate of adverse effects
Measured: Assessed at 3 month and 6 month follow up
PedsQL questionnaire score
Validated pediatric quality of life tool
Measured: Completed at baseline, 3 month and 6 month follow up
Masculinizing effects
Self reported, questionnaire
Measured: Completed at 3 month and 6 month follow up
Medication experience
Self reported, questionnaire
Measured: Completed at 3 month and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start26 Jan 2018
- Primary completion30 Jun 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services for Transgender PersonsStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized arm (SQ, IM), as well as non-randomized SQ and non-randomized IM.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara Connelly, Oregon Health and Science University
- Investigators
- Kara Connelly, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864913
- Sponsor's protocol ID
- STUDY00017454
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2019
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Subcutaneous Testosterone Compared to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents
- ClinicalTrials.gov ID
- NCT03864913
- Acronym / sponsor ID
- STUDY00017454
- Keywords
- Gender affirming care
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized arm (SQ, IM), as well as non-randomized SQ and non-randomized IM.
| Arm | Type | Receives |
|---|---|---|
| Randomized SQ vs IM | Experimental | Drug: Testosterone injection, Behavioral: PedsQL questionnarie, Other: Masculinizing effects questionnaire, Other: Medication experience questionnaireSubjects randomized to either SQ or IM testosterone injections follow study protocol. |
| Non-randomized SQ | Experimental | Drug: Testosterone injection, Behavioral: PedsQL questionnarie, Other: Masculinizing effects questionnaire, Other: Medication experience questionnaireSubjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol. |
| Non-randomized IM | Experimental | Drug: Testosterone injection, Behavioral: PedsQL questionnarie, Other: Masculinizing effects questionnaire, Other: Medication experience questionnaireSubjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Testosterone naive
- Transgender male
- 14-19 years old
Key exclusion criteria (1 listed)
- Transgender males who have received testosterone therapy in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone injectionSQ or IM testosterone injections for pubertal induction of transgender male adolescents. Increasing doses per protocol at 3 month and 6 month follow up. | Drug | Non-randomized IM, Non-randomized SQ, Randomized SQ vs IM |
| PedsQL questionnarieValidated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits. | Behavioural | Non-randomized IM, Non-randomized SQ, Randomized SQ vs IM |
| Masculinizing effects questionnaireSubjects complete self-reported questionnaire at 3 month and 6 month study visits. | Other | Non-randomized IM, Non-randomized SQ, Randomized SQ vs IM |
| Medication experience questionnaireSubjects complete self-reported questionnaire at 3 month and 6 month study visits. | Other | Non-randomized IM, Non-randomized SQ, Randomized SQ vs IM |
Primary outcome
Serum testosterone level
Time frame: Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up
Trough and peak serum testosterone level
4 secondary outcomes
Rate of adverse effects
Time frame: Assessed at 3 month and 6 month follow up
PedsQL questionnaire score
Time frame: Completed at baseline, 3 month and 6 month follow up
Masculinizing effects
Time frame: Completed at 3 month and 6 month follow up
Medication experience
Time frame: Completed at 3 month and 6 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Connelly, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Testosterone injection, PedsQL questionnarie and Masculinizing effects questionnaire in people with Health Services for Transgender Persons and Transgender Persons, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum testosterone level (time frame: Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.