Gender DysphoriaPhase 1/2STPNCT02229617
Subcutaneous Testosterone Project
A Phase 1/2 study testing Subcutaneous testosterone in people with Gender Dysphoria, run by University of British Columbia at 2 sites in Canada.
Trial summary
For people who identify as transgender, there is a strong sense that they were born into the wrong body and that their outward looking body does not match how they truly feel about themselves. They feel male, not female and have always felt that way. Read more about this study
- Who is it for?
- Ages 19 to 59 years, men only
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- Subcutaneous testosterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2015to May 2016
- Phase
- Phase 1/2
- 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 19 to 59 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Transgender males or identifying along the male spectrum
- Currently on stable doses of weekly IM testosterone
- Using either Testosterone cypionate or enanthate
- Between 19-59 years old
- Stable doses of regular medications
- Receive their transgender care from one of five(5) Vancouver-based physicians who specialize in transgender care (Three Bridges or Raven Song Community Health Centres).
Who cannot join
- Medically or psychiatrically unstable
- Recent or imminent surgery (6-8 weeks) that has or may affect testosterone dosage
- Unable to present for nine(9) weeks of weekly blood work and two(2) weeks of alternate day blood work
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Three Bridges Community Health Centre
Vancouver, British Columbia, V6Z 1W2
Raven Song Community Health Centre
Vancouver, British Columbia
About this study
Official title: A Pilot Study of Subcutaneous vs. Intramuscular Testosterone for Gender Affirming Therapy
For people who identify as transgender, there is a strong sense that they were born into the wrong body and that their outward looking body does not match how they truly feel about themselves. They feel male, not female and have always felt that way. There is a great deal of discomfort or dysphoria about looking and feeling female, and there is a strong desire to achieve a more masculine appearance. While surgery, clothing and hair for example, can help a person appear more like a male, many transgender males will want to take testosterone to make them feel and look more masculine.
This usually involves injecting testosterone into a muscle every 1-2 weeks for many years. Intramuscular injections can often be uncomfortable or painful, and requires the patient to be taught how to inject themselves. Or somebody else has to do it. There is a growing trend in some transgender men to give their injection just below the skin or subcutaneously (like insulin in a diabetic), because it is less uncomfortable but we don't really know if testosterone gets into the blood in the same way. At least one clinic in the US already suggests that patients can use the subcutaneous method but there is almost no research to show it's the same as intramuscular.
Our project will be looking at a small group of transgender males who are already on intramuscular testosterone and then switch them over to the same dose of subcutaneous testosterone, and then compare their levels of testosterone. If those levels are similar, then patients may chose the less uncomfortable subcutaneous injection.
Read the detailed description
Rationale:
In caring for transgender males (born female but identify as male), intramuscular (IM) testosterone is considered standard of care if they elect therapy to transition. Yet, IM testosterone has limitations: discomfort; a modest amount of teaching; bleeding concerns if the patient is on anticoagulants; and fluctuations in circulating serum testosterone. Erratic absorption may also led to variability in mood and energy. Due to these limitations, there is a trend, especially in younger patients, to use the more comfortable subcutaneous (SC) route. However, there are little data suggesting equivalency of SC to IM testosterone and virtually no data in transgender males.
Hypothesis:
In transgender males, SC testosterone will yield similar pharmacokinetics and better tolerability when compared to IM testosterone.
Objectives:
- To validate, using a cross-over design, whether pharmacokinetic parameters of SC vs. IM testosterone administration are similar.
- To characterize, using a validated pain questionnaire and patient diary, tolerability of SC vs. IM testosterone.
Research Plan:
Patients (19-59 years old) on a weekly self-injection schedule of either T cypionate or enanthate will be included. Patients with medical instability, recent or imminent surgery will be excluded. Twenty-five patients will be recruited from the 6 local Vancouver Coastal HealthTrans Primary Care physicians' clinics.
Using a cross-over design, trough serum testosterone levels from the IM technique will be determined weekly for 3 weeks. Patients will then switch to SC injection of the same testosterone ester and dosage, and weekly trough levels measured for another 8 weeks. These trough measurements will allow us to determine attainment of steady-state testosterone levels. During the 3rd and 11th week, serial testosterone levels will be collected to generate noncompartmental pharmacokinetic parameters, which will be compared between the two techniques. Patients will complete a validated pain analogue questionnaire during the initial 3-week IM phase, and again during weeks 2 and 8 of the SC phase and maintain a diary throughout the study. Descriptive and inferential statistics will be used with p<0.05 denoting significance.
Significance: If SC testosterone yields similar pharmacokinetics and better tolerability than IM testosterone, it will reduce the perceived barrier of IM injections and mitigate non-compliance. There are potential cost savings as patients will not require a clinician to inject. The findings may also be generalized to hypogonadal males. Ultimately, results are crucial to designing a larger multi-center study to provide definitive dosing recommendations.
- Conditions
- Gender Dysphoria
- Being tested
- Subcutaneous testosterone
- Keywords
- Intramuscular testosterone, Subcutaneous testosterone
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous testosteroneDrug
Also called Testosterone cypionate, Testosteron enanthate
| Study group | Role | What they receive |
|---|---|---|
| Injectable testosterone | Active comparator | We will take a group of transgender males, already on a stable dosage of intramuscular testosterone, and then using their same type and dosage, switch them to the subcutaneous injection route. Weekly trough (just before their weekly injection) levels of total serum testosterone will be taken to compare the steady states of those two injection routes. Receives: Drug: Subcutaneous testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Testosterone (Total)
To compare the steady state levels of total serum testosterone using the Subcutaneous (SC) and Intramuscular (IM) injection routes in a group of transgender males who are already on stable IM dosages.
Measured: 11 weeks
Secondary outcomes (1)
Pharmacokinetics of serum testosterone
We will be measuring alternate day serum testosterone levels during the subjects final week of IM testosterone injections (week #3) and the final week of SC testosterone injections (week #11).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Mary Ensom, Pharm D/PhD, Study director, University of British Columbia, Faculty of Pharmaceutical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229617
- Sponsor's protocol ID
- H14-00862
- Acronym
- STP
- Status last verified
- Jun 2016
- First submitted
- 28 Aug 2014
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Subcutaneous vs. Intramuscular Testosterone for Gender Affirming Therapy
- ClinicalTrials.gov ID
- NCT02229617
- Acronym / sponsor ID
- STP / H14-00862
- Conditions
- Gender Dysphoria
- Keywords
- Intramuscular testosterone, Subcutaneous testosterone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Sep 2014 (estimated)
- 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.
For people who identify as transgender, there is a strong sense that they were born into the wrong body and that their outward looking body does not match how they truly feel about themselves. They feel male, not female and have always felt that way. There is a great deal of discomfort or dysphoria about looking and feeling female, and there is a strong desire to achieve a more masculine appearance. While surgery, clothing and hair for example, can help a person appear more like a male, many transgender males will want to take testosterone to make them feel and look more masculine.
This usually involves injecting testosterone into a muscle every 1-2 weeks for many years. Intramuscular injections can often be uncomfortable or painful, and requires the patient to be taught how to inject themselves. Or somebody else has to do it. There is a growing trend in some transgender men to give their injection just below the skin or subcutaneously (like insulin in a diabetic), because it is less uncomfortable but we don't really know if testosterone gets into the blood in the same way. At least one clinic in the US already suggests that patients can use the subcutaneous method but there is almost no research to show it's the same as intramuscular.
Our project will be looking at a small group of transgender males who are already on intramuscular testosterone and then switch them over to the same dose of subcutaneous testosterone, and then compare their levels of testosterone. If those levels are similar, then patients may chose the less uncomfortable subcutaneous injection.
Detailed description
Rationale:
In caring for transgender males (born female but identify as male), intramuscular (IM) testosterone is considered standard of care if they elect therapy to transition. Yet, IM testosterone has limitations: discomfort; a modest amount of teaching; bleeding concerns if the patient is on anticoagulants; and fluctuations in circulating serum testosterone. Erratic absorption may also led to variability in mood and energy. Due to these limitations, there is a trend, especially in younger patients, to use the more comfortable subcutaneous (SC) route. However, there are little data suggesting equivalency of SC to IM testosterone and virtually no data in transgender males.
Hypothesis:
In transgender males, SC testosterone will yield similar pharmacokinetics and better tolerability when compared to IM testosterone.
Objectives:
- To validate, using a cross-over design, whether pharmacokinetic parameters of SC vs. IM testosterone administration are similar.
- To characterize, using a validated pain questionnaire and patient diary, tolerability of SC vs. IM testosterone.
Research Plan:
Patients (19-59 years old) on a weekly self-injection schedule of either T cypionate or enanthate will be included. Patients with medical instability, recent or imminent surgery will be excluded. Twenty-five patients will be recruited from the 6 local Vancouver Coastal HealthTrans Primary Care physicians' clinics.
Using a cross-over design, trough serum testosterone levels from the IM technique will be determined weekly for 3 weeks. Patients will then switch to SC injection of the same testosterone ester and dosage, and weekly trough levels measured for another 8 weeks. These trough measurements will allow us to determine attainment of steady-state testosterone levels. During the 3rd and 11th week, serial testosterone levels will be collected to generate noncompartmental pharmacokinetic parameters, which will be compared between the two techniques. Patients will complete a validated pain analogue questionnaire during the initial 3-week IM phase, and again during weeks 2 and 8 of the SC phase and maintain a diary throughout the study. Descriptive and inferential statistics will be used with p<0.05 denoting significance.
Significance: If SC testosterone yields similar pharmacokinetics and better tolerability than IM testosterone, it will reduce the perceived barrier of IM injections and mitigate non-compliance. There are potential cost savings as patients will not require a clinician to inject. The findings may also be generalized to hypogonadal males. Ultimately, results are crucial to designing a larger multi-center study to provide definitive dosing recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injectable testosterone | Active comparator | Drug: Subcutaneous testosteroneWe will take a group of transgender males, already on a stable dosage of intramuscular testosterone, and then using their same type and dosage, switch them to the subcutaneous injection route. Weekly trough (just before their weekly injection) levels of total serum testosterone will be taken to compare the steady states of those two injection routes. |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Transgender males or identifying along the male spectrum
- Currently on stable doses of weekly IM testosterone
- Using either Testosterone cypionate or enanthate
- Between 19-59 years old
- Stable doses of regular medications
Key exclusion criteria (3 listed)
- Medically or psychiatrically unstable
- Recent or imminent surgery (6-8 weeks) that has or may affect testosterone dosage
- Unable to present for nine(9) weeks of weekly blood work and two(2) weeks of alternate day blood work
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 |
|---|---|---|
| Subcutaneous testosteroneAlso: Testosterone cypionate, Testosteron enanthate | Drug | Injectable testosterone |
Primary outcome
Serum Testosterone (Total)
Time frame: 11 weeks
To compare the steady state levels of total serum testosterone using the Subcutaneous (SC) and Intramuscular (IM) injection routes in a group of transgender males who are already on stable IM dosages.
1 secondary outcome
Pharmacokinetics of serum testosterone
Time frame: 2 weeks
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 6 Jun 2016.
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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.
Mary Ensom, Pharm D/PhD study director
University of British Columbia, Faculty of Pharmaceutical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Subcutaneous testosterone in people with Gender Dysphoria, run by University of British Columbia at 2 sites in Canada.
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 6 inclusion and 3 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 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (Total) (time frame: 11 weeks). 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 6 Jun 2016.