E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Tuesday, November 19, 2013

E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy



ClinicalTrials.gov

This study is currently recruiting participants.

Verified November 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
C. Neill Epperson, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01986764
First received: October 30, 2013
Last updated: November 11, 2013
Last verified: November 2013
 
Purpose
This project seeks to address cognitive disturbance, which is a frequent adverse sequelae of risk reducing 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 BRCA1/BRCA2 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®).

Condition Intervention
Planned RRSO
Drug: LDX
Drug: Estradiol
Drug: Placebo

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