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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2016 |
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Main ID: |
NCT02229617 |
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Date of registration:
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28/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Subcutaneous Testosterone Project
STP |
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Scientific title:
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A Pilot Study of Subcutaneous vs. Intramuscular Testosterone for Gender Affirming Therapy |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02229617 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Mary Ensom, Pharm D/PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia, Faculty of Pharmaceutical Sciences |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
59 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Gender Dysphoria
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Intervention(s)
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Drug: Subcutaneous testosterone
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Primary Outcome(s)
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Serum Testosterone (Total)
[Time Frame: 11 weeks]
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Secondary Outcome(s)
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Pharmacokinetics of serum testosterone
[Time Frame: 2 weeks]
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Secondary ID(s)
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H14-00862
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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