Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
NCT ID: NCT04596592
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2021-02-15
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Transgender
No interventions assigned to this group
Cisgender
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
13 Years
16 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Natalie Nokoff, MD, MSCS
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-1226
Identifier Type: -
Identifier Source: org_study_id
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