RECRUITING

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Quick Facts

Study Start:2021-02-15
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04596592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
  2. * Antipsychotic medication use
  3. * Type 1 or 2 diabetes (by medical history)
  4. * Polycystic ovarian syndrome (PCOS for cisgender females)
  5. * Hypertension (resting BP ≥ 140/90 mm/Hg)
  6. * Weight\> 400 lbs
  7. * On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant)
  8. * Pregnancy (for cisgender females)

Contacts and Locations

Study Contact

Natalie Nokoff, MD, MSCS
CONTACT
720-777-3607
Natalie.Nokoff@childrenscolorado.org

Principal Investigator

Natalie Nokoff, MD, MSCS
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Natalie Nokoff, MD, MSCS, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-15
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2021-02-15
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Transgenderism
  • Gender Dysphoria
  • Insulin Sensitivity