E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy (NCT01986764) | Clinical Trial Compass
WithdrawnNot Applicable
E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy
Stopped: Funding was not obtained for this study and no participants were enrolled.
United States0Started 2013-07-01
Plain-language 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 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®).
Who can participate
Age range
30 Years – 48 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have no previous or present history of a DSM-IV psychiatric disorder within the previous year or substance dependence disorder within the previous 5 years (psychostimulant abuse lifetime history), according to the Structured Clinical Interview for Diagnosis- DSM-IV (SCID)-Non-Patient Version;
. Planning to undergo an oophorectomy or full hysterectomy;
. Are premenopaual (have a baseline follicle stimulating hormone level (FSH) of \<20 IU/ml);
. Smoke \< 10 cigarettes per day
. Are right-handed;
. Can provide proof of having had a gynecological exam and PAP test done within the previous 3 years at the time of screening;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Can provide proof of having had a mammogram within the previous 12 months at the time of screening;
. Are able to give written informed consent;
Exclusion criteria
. Mini-mental status exam score of less than or equal to 24;
. Presence of a psychiatric disorder within previous year or a life time history of ADHD or psychotic disorder including bipolar disorder, schizoaffective disorder and schizophrenia;
. Lifetime history of drug addiction or abuse, excepting nicotine;
. Regular use of other psychotropic medication;
. Regular use (more than once a week) of alcohol that is greater than 3 drinks per day;
. Presence of a contraindication to treatment with stimulant medication; this would include the presence of hypertension (controlled or uncontrolled), coronary disease, atrial fibrillation, and arrhythmia;
. History of seizures;
. Presence of a contraindication to treatment with estrogen; this would include the presence of a history of blood clots, and estrogen-receptor positive breast cancer;