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OpenTrials
Completed

NCT Number: NCT02550431

Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth

This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.

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Key information

Conditions

Transgendered Persons

Age range

9 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Followed in Endocrinology Clinic or Adolescent Medicine Clinic at Children's Hospital Colorado
  • Between age 9 and 21 years (inclusive)
  • Identifies as transgender
  • Has been on pubertal blockade or cross-sex hormones for at least three months.

Exclusion criteria

  • Known diabetes
  • Presence of significant medical or psychiatric comorbidities
  • Using hormones not prescribed by a physician

Treatment and study plan

Primary outcomes

  1. Reproductive hormone concentrations in transgender youth on cross-sex hormones and/or puberty blockers and compared to age-, natal sex- and body mass index (BMI)-matched controls.

    Time frame: at enrollment

  2. Markers of cardiometabolic risk in transgender youth on cross-sex hormones and/or puberty blockers and compared to age-, natal sex- and BMI-matched controls

    Time frame: at enrollment

  3. Body composition as measured by Dual-energy X-ray absorptiometry (DEXA) in transgender youth compared to age- and BMI-matched controls of both sexes.

    Time frame: at enrollment

  4. Data on quality of life as measured by the Pediatric Quality of Life Inventory (PedsQL) compared to published norms

    Time frame: at enrollment

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2015
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.