Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Launched by UNIVERSITY OF COLORADO, DENVER · Oct 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how estradiol, a hormone often taken by transgender females, affects insulin sensitivity (how well the body uses sugar) and blood vessel function. The researchers want to see if starting estradiol after using a medicine that blocks puberty has different effects compared to those who do not use this puberty blocker. They will be comparing transgender females with cisgender males and females, all between the ages of 13 and 16.

To participate, transgender females need to identify as such and plan to start estradiol treatment within the next four months. They should also have been on a puberty-blocking medication for at least six months. Cisgender males and females can also join the study, as long as they are in the same age range. Participants will undergo some tests to measure their insulin sensitivity and blood flow, and they will be closely monitored throughout the study. It’s important to know that certain health conditions or medications may prevent someone from being eligible for this trial.

Gender

ALL

Eligibility criteria

• 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)