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NCT Number: NCT04596592

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

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.

Recruiting

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Key information

Conditions

Transgenderism Behavior Gender Dysphoria Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Sexual Behavior Sexual Dysfunctions, Psychological Sexuality Transsexualism

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Natalie Nokoff, MD

CONTACT

[email protected]

720-777-3607

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(transgender females):

  • 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

Inclusion criteria

(cisgender males and females):

  • Males and females ages 13-16 years

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Insulin sensitivity

    Time frame: Change from baseline to 12 months

  2. Brachial artery flow mediated dilation

    Time frame: Change from baseline to 12 months

Secondary outcomes

  1. Large artery stiffness

    Time frame: Change from baseline to 12 months

    Carotid artery ultrasound

  2. Cerebrovascular function

    Time frame: Change from baseline to 12 months

    Middle cerebral artery blood flow

  3. VO2 peak

    Time frame: Change from baseline to 12 months

  4. Fat mass

    Time frame: Change from baseline to 12 months

    DXA

  5. Fat-free mass

    Time frame: Change from baseline to 12 months

    DXA

Study contacts

Contact information is provided by the study sponsor or research team.

Natalie Nokoff, MD, MSCS

CONTACT

[email protected]

720-777-3607

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: PUBERTY

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2020
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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