Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450405
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-30
Brief Title:
Androgen Effects on the Reproductive Neuroendocrine Axis
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Androgen Effects on the Reproductive Neuroendocrine Axis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy non-PCOS females
Detailed Description:
Testosterone Replacement Therapy TRT is the mainstay of gender affirming care for transgender men TGM who have male gender identity after female sex assignment at birth TGM receiving TRT over time exhibit irregular menstrual bleeding however the mechanism of menstrual disruption is unknown Therefore the investigators propose to evaluate the effect of chronic testosterone T exposure on ovarian hormones and pituitary gonadotropin release that determines menstrual cyclicity The investigators will conduct a detailed study of blood reproductive hormone secretion in TGM before and during TRT as well as in untreated cisgender female CGF control subjects who report female gender identity congruent with female sex assignment at birth The investigators will also perform periodic clinical and ultrasonographic evaluations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD111650-01 | NIH | None | httpsreporternihgovquickSearch1R01HD111650-01 |