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Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth (PUBERTY)

Study category: Healthy Volunteers

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Description

This study will involve 6 research visits at 3 timepoints for transgender individuals (before starting estrogen and 6 and 12 months after starting estrogen). No medications are given as a part of this study. Cisgender (non-transgender) participants will have 4 visits at two timepoints (baseline and 12 months later). Research visits will include a physical exam, questionnaires, a blood draw, drinking a sugary drink, ultrasounds of the head, neck and arm, riding an exercise bike and a body scan.

Details
Age

Child

Eligibility

Adolescents ages 13-16 years old (transgender females and cisgender males and females)

Detailed Eligibility: Transgender participants should have 13-16 years old and be planning on clinically starting estrogen (estradiol) within the next 4 months. If they have been on a puberty blocker, should have been on at least 6 months.

Phase

Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.

Type of Study

Observational

Locations

Childrens Hospital Colorado
University of Colorado Hospital

Principal Investigator
Natalie Nokoff

Natalie Nokoff

Study ID

Protocol Number: 19-1226

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