Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
PUBERTY
2 other identifiers
observational
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
June 10, 2025
June 1, 2025
5.5 years
September 28, 2020
June 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Insulin sensitivity
Change from baseline to 12 months
Brachial artery flow mediated dilation
Change from baseline to 12 months
Secondary Outcomes (5)
Large artery stiffness
Change from baseline to 12 months
Cerebrovascular function
Change from baseline to 12 months
VO2 peak
Change from baseline to 12 months
Fat mass
Change from baseline to 12 months
Fat-free mass
Change from baseline to 12 months
Study Arms (2)
Transgender
Cisgender
Eligibility Criteria
Transgender and cisgender adolescents
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Biospecimen
Optional consent for DNA collection and storage
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natalie Nokoff, MD, MSCS
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2020
First Posted
October 22, 2020
Study Start
February 15, 2021
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
June 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share