Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04596592

Acronym

PUBERTY

Enrollment

Registered

2020-10-22

Start date

2021-02-15

Completion date

2026-07-31

Last updated

2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender Dysphoria, Insulin Sensitivity, Transgenderism

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

13 Years to 16 Years

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)

Design outcomes

Primary

Measure	Time frame
Insulin sensitivity	Change from baseline to 12 months
Brachial artery flow mediated dilation	Change from baseline to 12 months

Secondary

Measure	Time frame	Description
VO2 peak	Change from baseline to 12 months	—
Large artery stiffness	Change from baseline to 12 months	Carotid artery ultrasound
Fat-free mass	Change from baseline to 12 months	DXA
Fat mass	Change from baseline to 12 months	DXA
Cerebrovascular function	Change from baseline to 12 months	Middle cerebral artery blood flow

Countries

United States

Contacts

Primary ContactNatalie Nokoff, MD, MSCS

Natalie.Nokoff@childrenscolorado.org720-777-3607

Outcome results