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)

Children's Hospital Colorado

Aurora, Colorado, United States

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NCT04596592


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