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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT04321551
Eligibility Criteria:
* Self-identified transgender or non-binary person assigned female at birth
* No history of prior testosterone therapy
* Regular menstrual cycles
* Body mass index 18 - 35
* Hemoglobin greater than than 11 gm/dl at screening evaluation
* Presence of uterus and both ovaries at time of consent
* Able to provide informed consent
* No current endocrine disease- including, but not limited to, pituitary disease, adrenal disease, androgen secreting tumor, polycystic ovary syndrome, diabetes, or untreated thyroid disease.
* Absence of cancer and any renal, hepatic, or cardiac disease
* No current use of endocrine modulating medications (including, but not limited to, progestin therapy, estrogen containing medications, metformin, insulin)
* No history of radiation or surgery involving brain, abdomen, or pelvis
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT04321551
Study Brief:
Protocol Section:
NCT04321551