Actively Recruiting

Age: 13Years - 16Years
All Genders
NCT04596592

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Led by University of Colorado, Denver · Updated on 2025-06-10

90

Participants Needed

1

Research Sites

284 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Who Can Participate

Age: 13Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Identify as a transgender female
  • Age 13-16 years at the time of enrollment
  • If on a gonadotropin releasing hormone analogue, more than 6 months exposure
  • Plan to start estradiol clinically in less than 4 months
  • Cisgender males and females ages 13-16 years
Not Eligible

You will not qualify if you...

  • Cognitive, psychiatric, or physical impairment preventing study procedure tolerance
  • Use of antipsychotic medications
  • History of type 1 or type 2 diabetes
  • Polycystic ovarian syndrome (for cisgender females)
  • Hypertension with resting blood pressure equal or above 140/90 mm/Hg
  • Weight over 400 lbs
  • Use of oral progesterone medications including combined oral contraceptives or etonogestrel implant
  • Pregnancy (for cisgender females)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

N

Natalie Nokoff, MD, MSCS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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