Subcutaneous Testosterone Project (STP)
Primary Purpose
Gender Dysphoria
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Subcutaneous testosterone
Sponsored by
About this trial
This is an interventional treatment trial for Gender Dysphoria focused on measuring Intramuscular testosterone, Subcutaneous testosterone
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
- Three Bridges Community Health Centre
- Raven Song Community Health Centre
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Injectable testosterone
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT02229617
First Posted
August 28, 2014
Last Updated
June 2, 2016
Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02229617
Brief Title
Subcutaneous Testosterone Project
Acronym
STP
Official Title
A Pilot Study of Subcutaneous vs. Intramuscular Testosterone for Gender Affirming Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Dysphoria
Keywords
Intramuscular testosterone, Subcutaneous testosterone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injectable testosterone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Subcutaneous testosterone
Other Intervention Name(s)
Testosterone cypionate, Testosteron enanthate
Primary Outcome Measure Information:
Title
Serum Testosterone (Total)
Description
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.
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics of serum testosterone
Description
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).
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Tolerability and discomfort assessment
Description
Study participants will complete a weekly questionnaire regarding tolerability and discomfort, as well as a final questionnaire asking for preferred method of injection.
Time Frame
11 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Ensom, Pharm D/PhD
Organizational Affiliation
University of British Columbia, Faculty of Pharmaceutical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Three Bridges Community Health Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1W2
Country
Canada
Facility Name
Raven Song Community Health Centre
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
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Subcutaneous Testosterone Project
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