Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460948
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Brief Title:
Identifying Oxytocin Deficiency in Adults With Pituitary Disease
Sponsor:
Elizabeth Austen Lawson
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Characterizing Oxytocin Response to Oral Estrogen Administration in Adults With Arginine Vasopressin Deficiency
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 is an open-label pilot study to characterize oxytocin response to a single dose of oral Estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls The association between oxytocin levels and measures of psychopathology ie anxiety and depression and quality of life across groups will be examined We hypothesize that
1 Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control
2 Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety depression and social emotional difficulties as well as lower quality of life
1 Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control
2 Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety depression and social emotional difficulties as well as lower quality of life
Detailed Description:
None
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