Recruiting

Pubertal Blockade & Estradiol

Sponsor:

University of Colorado, Denver

Code:

NCT04596592

Conditions

Transgenderism

Gender Dysphoria

Insulin Sensitivity

Eligibility Criteria

Sex: All

Age: 13 - 16

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Transgenderism

Gender Dysphoria

Insulin Sensitivity

Study ID

NCT04596592

Start date

Feb 15, 2021

Status verified date

Jun, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria (transgender females):

  • 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

Inclusion Criteria (cisgender males and females):

  • Males and females ages 13-16 years

Exclusion Criteria:

  • 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)

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Transgender

Cisgender

Primary outcome measure

  • Insulin sensitivity [ Time Frame: Change from baseline to 12 months ]
  • Brachial artery flow mediated dilation [ Time Frame: Change from baseline to 12 months ]

Central Contacts and Locations

Central contacts

Natalie Nokoff, MD, MSCS

720-777-3607Natalie.Nokoff@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Natalie Nokoff, MD

720-777-3607natalie.nokoff@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 10, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-06-10.