Pubertal Blockade and Hormone Therapy in Transgender Youth (NCT03557268) | Clinical Trial Compass
CompletedNot Applicable
Pubertal Blockade and Hormone Therapy in Transgender Youth
United States19 participantsStarted 2018-06-19
Plain-language summary
This study will enroll female-to-male transgender youth who are and are not on a puberty blocker (gonadotropin-releasing hormone analogue) at baseline and 1 and 12 months after starting testosterone. The study will evaluate markers of cardiometabolic health including: insulin sensitivity, laboratory markers, vascular health, body composition, activity/fitness, mitochondrial function and the microbiome.
Who can participate
Age range
13 Years – 16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Identify as female-to-male
* Age 13-16 years at the time of enrollment
* If on a gonadotropin-releasing hormone analogue, \> 6 months exposure
* Plan to start testosterone clinically in \< 6 months.
Exclusion Criteria:
* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
* Diabetes
* Antipsychotic medication
* Hypertension (resting BP ≥ 140/90 mm/Hg)
* Weight \> 400 lbs (DXA and MRI limit)
* On estrogen and/or progesterone medications
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Insulin sensitivity
Timeframe: Baseline and 12 months after initiation of testosterone.
2
Change in Vascular Health
Timeframe: Baseline and 12 months after initiation of testosterone.