Subcutaneous Testosterone Project

NCT02229617 | Completed Phase 1

• 1 other identifier: H14-00862
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Gender Dysphoria

Keywords

Intramuscular testosterone; Subcutaneous testosterone

Outcome Measures

Primary Outcomes (1)

• 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.

  11 weeks

Secondary Outcomes (1)

• Pharmacokinetics of serum testosterone

  2 weeks

Other Outcomes (1)

• Tolerability and discomfort assessment

  11 weeks

Study Arms (1)

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.

Drug: Subcutaneous testosterone

Interventions

Subcutaneous testosterone DRUG

Also known as: Testosterone cypionate, Testosteron enanthate

Injectable testosterone

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health Research Institute: collaborator

Study Sites (2)

Three Bridges Community Health Centre

Vancouver, British Columbia, V6Z 1W2, Canada

Location

Raven Song Community Health Centre

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Gender Dysphoria

Interventions

testosterone 17 beta-cypionate

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Mary Ensom, Pharm D/PhD

  University of British Columbia, Faculty of Pharmaceutical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 6, 2016

Record last verified: 2016-06

Locations

CA (2)