Pubertal Blockade and Estradiol Effects on Cardiometaboli... | NCT04596592

Studies
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

NCT04596592

Sponsor

University of Colorado, Denver

Status

Recruiting

Last Update Posted

Jun 10, 2025Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Transgenderism
Gender Dysphoria
Insulin Sensitivity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1K23HL151868-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2021Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Sep 28, 2020

First Submission Date that Met QC Criteria

Oct 20, 2020

First Posted Date

Oct 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2025

Last Update Posted Date

Jun 10, 2025Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Large artery stiffness	Carotid artery ultrasound	Change from baseline to 12 months
Cerebrovascular function	Middle cerebral artery blood flow

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Transgender and cisgender adolescents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Natalie Nokoff, MD, MSCS	Contact	720-777-3607		Natalie.Nokoff@childrenscolorado.org

Overall Officials

Name	Affiliation	Role
Natalie Nokoff, MD, MSCS	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Colorado	Recruiting	Aurora	Colorado	80045	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014189	Transsexualism
D000068116	Gender Dysphoria
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D019529	Sexuality
D012725	Sexual Behavior
D001519	Behavior
D020018	Sexual Dysfunctions, Psychological

Browse Leaves

Not provided

Browse Branches

Not provided