RecruitingNCT04596592
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
Sponsor
University of Colorado, Denver
Enrollment
90 participants
Start Date
Feb 15, 2021
Study Type
OBSERVATIONAL
Conditions
Summary
To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.
Eligibility
Min Age: 13 YearsMax Age: 16 Years
Inclusion Criteria5
- Identify as a transgender female
- Age 13-16 years at the time of enrollment
- If on a gonadotropin releasing hormone analogue, > 6 months exposure
- Plan to start estradiol clinically in < 4 months
- Males and females ages 13-16 years
Exclusion Criteria8
- Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
- Antipsychotic medication use
- Type 1 or 2 diabetes (by medical history)
- Polycystic ovarian syndrome (PCOS for cisgender females)
- Hypertension (resting BP ≥ 140/90 mm/Hg)
- Weight> 400 lbs
- On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant)
- Pregnancy (for cisgender females)
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04596592
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