Ignite Creation Date:
2024-05-06 @ 2:10 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01986764
Status:
WITHDRAWN
Last Update Posted:
2017-03-24
First Post:
2013-10-30
Brief Title:
E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Predictors of Healthy Mood and Memory After Oophorectomy
Status:
WITHDRAWN
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding was not obtained for this study and no participants were enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E2LDX
Brief Summary:
This project seeks to address cognitive disturbance which is a frequent adverse sequelae of riskreducing bilateral salpingo-oophorectomy RRSO with or without post-procedure chemotherapy and adjunctive treatments RRSO after completion of childbearing is recommended for prevention of ovarian and breast cancer in women with BRCA1BRCA2 mutations and standard of care for women with some forms of hormone-responsive cancer Knowledge regarding the impact of this procedure with or without chemotherapy and subsequent hypogonadism on brain health is less than adequate Premenopausal women who undergo an acute surgical menopause are at greater risk for verbal memory decline and executive function EF complaints but as of yet we cannot predict who is going to experience these adverse sequelae nor do we have targeted prevention or treatment strategies other than hormone therapy which is not an option in many cases and not always effective An idealized sample as women who are planning for a RRSO will undergo brain imaging and behavioral assessments pre- and post-surgery as well as pre-post-treatment with E2 or the psychostimulant lisdexamphetamine LDX Vyvanse
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None