Status:
WITHDRAWN
Hormone Secretion in Transgender Males
Lead Sponsor:
University of California, San Diego
Conditions:
Transgender
Healthy
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
Brief Summary
Aim 1 utilizes prospective clinical studies in TGN to test the hypothesis that prolonged exogenous androgens alter menstrual cyclicity by inhibiting gonadotropin secretion, steroid hormone release, an...
Detailed Description
We will conduct a prospective, controlled clinical trial of ovarian and menstrual cyclicity in TGN initiating TRT (Fig. 8). Enrollment will include 30 TGN and 30 cisgender female (CF) control subjects...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04321551
Start Date
July 1 2023
End Date
December 31 2028
Last Update
January 13 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.