TransgenderismPUBERTYNCT04596592
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
An observational study of Transgenderism and Gender Dysphoria, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Transgenderism, Gender Dysphoria, Insulin Sensitivity
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 to 16 years
- All sexes
- Child
Study population: Transgender and cisgender adolescents
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Natalie Nokoff, MD, 720-777-3607, natalie.nokoff@childrenscolorado.org
About this study
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.
- Conditions
- Transgenderism, Gender Dysphoria, Insulin Sensitivity
- Medical subject headings
- Transsexualism, Gender Dysphoria, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transgender | Not described | |
| Cisgender | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: Change from baseline to 12 months
Brachial artery flow mediated dilation
Measured: Change from baseline to 12 months
Secondary outcomes (5)
Large artery stiffness
Carotid artery ultrasound
Measured: Change from baseline to 12 months
Cerebrovascular function
Middle cerebral artery blood flow
Measured: Change from baseline to 12 months
VO2 peak
Measured: Change from baseline to 12 months
Fat mass
DXA
Measured: Change from baseline to 12 months
Fat-free mass
DXA
Measured: Change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Feb 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Natalie Nokoff, MD, MSCS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596592
- Sponsor's protocol ID
- 19-1226
- Other IDs
- 1K23HL151868-01
- Acronym
- PUBERTY
- Status last verified
- Jun 2025
- First submitted
- 28 Sep 2020
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
- ClinicalTrials.gov ID
- NCT04596592
- Acronym / sponsor ID
- PUBERTY / 19-1226
- Conditions
- Transgenderism, Gender Dysphoria, Insulin Sensitivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 22 Oct 2020 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgender | – | – |
| Cisgender | – | – |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Transgender and cisgender adolescents
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
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
Insulin sensitivity
Time frame: Change from baseline to 12 months
Brachial artery flow mediated dilation
Time frame: Change from baseline to 12 months
5 secondary outcomes
Large artery stiffness
Time frame: Change from baseline to 12 months
Cerebrovascular function
Time frame: Change from baseline to 12 months
VO2 peak
Time frame: Change from baseline to 12 months
Fat mass
Time frame: Change from baseline to 12 months
Fat-free mass
Time frame: Change from baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Natalie Nokoff, MD, MSCS 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 Transgenderism and Gender Dysphoria, 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Nokoff, MD, MSCS (720-777-3607, Natalie.Nokoff@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Change from baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.