Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT04596592
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)
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
16 Years
Study:
NCT04596592
Study Brief:
Protocol Section:
NCT04596592