Transgendered PersonsNCT02550431
Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth
An observational study of Transgendered Persons, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 21 years
- Conditions the study is for
- Transgendered Persons
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 26 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Transgender youth ages 9 to 21 years of age who have been on a Gonadotropin-releasing hormone (GnRH) agonist or cross-sex hormones for at least three months
Who may be able to join
- 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.
Who cannot join
- Known diabetes
- Presence of significant medical or psychiatric comorbidities
- Using hormones not prescribed by a physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
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.
Read the detailed description
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.
- Conditions
- Transgendered Persons
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at enrollment
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
Measured: at enrollment
Body composition as measured by Dual-energy X-ray absorptiometry (DEXA) in transgender youth compared to age- and BMI-matched controls of both sexes.
Measured: at enrollment
Data on quality of life as measured by the Pediatric Quality of Life Inventory (PedsQL) compared to published norms
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startMar 2016
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transgendered PersonsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie J Nokoff, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550431
- Sponsor's protocol ID
- 15-1215
- Other IDs
- UL1TR001082
- Status last verified
- Jan 2018
- First submitted
- 11 Sep 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Nokoff NJ, Scarbro SL, Moreau KL, Zeitler P, Nadeau KJ, Reirden D, Juarez-Colunga E, Kelsey MM. Body Composition and Markers of Cardiometabolic Health in Transgender Youth on Gonadotropin-Releasing Hormone Agonists. Transgend Health. 2021 Apr 16;6(2):111-119. doi: 10.1089/trgh.2020.0029. eCollection 2021 Apr.
PubMed 33937527Nokoff NJ, Scarbro SL, Moreau KL, Zeitler P, Nadeau KJ, Juarez-Colunga E, Kelsey MM. Body Composition and Markers of Cardiometabolic Health in Transgender Youth Compared With Cisgender Youth. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e704-14. doi: 10.1210/clinem/dgz029.
PubMed 31544944
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth
- ClinicalTrials.gov ID
- NCT02550431
- Acronym / sponsor ID
- 15-1215
- Conditions
- Transgendered Persons
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 9 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Transgender youth ages 9 to 21 years of age who have been on a Gonadotropin-releasing hormone (GnRH) agonist or cross-sex hormones for at least three months
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Known diabetes
- Presence of significant medical or psychiatric comorbidities
- Using hormones not prescribed by a physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Data on quality of life as measured by the Pediatric Quality of Life Inventory (PedsQL) compared to published norms
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 33937527Nokoff NJ, Scarbro SL, Moreau KL, Zeitler P, Nadeau KJ, Reirden D, Juarez-Colunga E, Kelsey MM. Body Composition and Markers of Cardiometabolic Health in Transgender Youth on Gonadotropin-Releasing Hormone Agonists. Transgend Health. 2021 Apr 16;6(2):111-119. doi: 10.1089/trgh.2020.0029. eCollection 2021 Apr.
- Derived from this study: PubMed 31544944Nokoff NJ, Scarbro SL, Moreau KL, Zeitler P, Nadeau KJ, Juarez-Colunga E, Kelsey MM. Body Composition and Markers of Cardiometabolic Health in Transgender Youth Compared With Cisgender Youth. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e704-14. doi: 10.1210/clinem/dgz029.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie J Nokoff, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgendered Persons, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02550431, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.