Testosterone for Headache
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how starting testosterone treatment affects headaches and brain changes in transmasculine youth. Researchers aim to determine if testosterone impacts pain, drawing on observations from other groups. Participants will include transmasculine youth planning to start testosterone soon, regardless of prior puberty blocker use. They will visit four times over two years for health surveys, a brain MRI, and blood samples. Participants will also maintain a headache diary during specific periods of the study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance understanding and treatment for future patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on a puberty blocker, you must have started it at least 3 months before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that testosterone therapy is generally safe for transmasculine individuals. Many studies have examined its effects, and while some side effects may occur, most people manage well. Common issues might include acne or mood changes, but serious problems are rare.
For those who have used puberty blockers (GnRH agonists), these are also considered safe for teenagers. Some studies have noted a possible decrease in bone strength during treatment. However, doctors usually monitor this to ensure safety.
Overall, both treatments have been safely used by many people, but discussing any concerns with a doctor is important. They can offer advice based on individual health needs and monitor for any side effects.12345Why are researchers excited about this trial?
Researchers are excited about studying the impact of testosterone on brain development in transmasculine youth because it could provide insights into how puberty blockers and testosterone shape neurological outcomes. Unlike typical treatments that focus solely on physical transitions, this study examines cognitive and developmental changes. By comparing youth who have used puberty blockers with those who haven't, scientists aim to understand how these interventions might differently influence brain development. This research could lead to more personalized and effective approaches in gender-affirming care.
What evidence suggests that testosterone treatment could be effective for changes in headache in transmasculine youth?
Research shows that testosterone treatment can influence pain levels. Studies involving cisgender women (those whose sex and gender identity are female) and transmasculine adults (those assigned female at birth but who identify as male) suggest that testosterone might change how pain is felt. Although specific information about headaches is limited, these findings indicate that testosterone could affect headache patterns.
In this trial, transmasculine youth will be divided into two groups: those who have been on a pubertal blocker, a gonadotropin hormone-releasing (GnRH) agonist, for at least 3 months, and those with no history of pubertal blocker use. Puberty blockers temporarily stop puberty, which helps transgender youth, including those starting testosterone, by preventing the development of unwanted physical traits. Studies indicate that this can improve individuals' feelings about their appearance and enhance overall mental well-being.13678Who Is on the Research Team?
Jennifer Hranilovich
Principal Investigator
Children's Hospital Colorado
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments including health surveys, brain MRI, blood sample, and physical exam before starting testosterone
Treatment
Participants receive testosterone treatment and are monitored at 6 months, 1 year, and 2 years with health surveys, brain MRI, and blood samples
Follow-up
Participants are monitored for changes in headache and brain structure/function after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Testosterone
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Transmasculine youth who will begin taking testosterone clinically in \< 6 months with or without headache and who have been on pubertal blocker, a gonadotropin hormone releasing (GnRH) agonist for at least 3 months.
Transmasculine youth who will begin taking testosterone clinically in \< 6 months with or without headache and who have no history of pubertal blocker.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Citations
Effectiveness of Puberty Suppression with Gonadotropin ...
Conclusions: GnRHa are effective in suppressing the HPG axis in transgender youth, similar to that observed in children with CPP. Keywords: puberty suppression, ...
Psychosocial Functioning in Transgender Youth after 2 ...
In this 2-year study involving transgender and nonbinary youth, GAH improved appearance congruence and psychosocial functioning.
Puberty suppression in adolescents with gender dysphoria
GnRHa are effective in HPG axis suppression in transgender adolescents, similarly to central precocious puberty (CPP). A retrospective review of ...
Interventions to suppress puberty in adolescents experiencing ...
Effectiveness of puberty suppression with Gonadotropin-releasing hormone agonists in Transgender youth. Transgend Health 2021;6:31–5. doi ...
Gender affirming medical care of transgender youth - PMC
Treatment with gonadotropin releasing hormone agonists are used to block puberty. Their function is many-fold: to pause puberty so that the youth may explore ...
Experience with gender affirming hormones and puberty ...
We aimed to qualitatively evaluate the sexual experience of TGNB individuals during GAMT and identify significant and consistent themes that arose from our ...
Psychological and Physical Health Outcomes Associated ...
The most common forms of GAMC sought out by and offered to TGD youth are puberty blockers and hormone therapy, both of which are only recommended to youth after ...
Gender-Affirming Care of Transgender and ...
This review will focus on current concepts of TGD youth, impact of gender-affirming care, gaps in knowledge, challenges to care, and priorities for research.
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