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E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy (E2LDX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986764
Recruitment Status : Withdrawn (Funding was not obtained for this study and no participants were enrolled.)
First Posted : November 18, 2013
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
C. Neill Epperson, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE October 30, 2013
First Posted Date  ICMJE November 18, 2013
Last Update Posted Date March 24, 2017
Actual Study Start Date  ICMJE July 1, 2013
Actual Primary Completion Date July 1, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
BADDS Score [ Time Frame: 12 weeks ]
This study uses a double-blind, placebo-controlled, design. The primary subjective outcome variable is the BADDS score measured at the initial screening visit, and one week after oophorectomy and 12 weeks after randomization to E2, LDX or placebo post-oophorectomy. The primary, out-of-scan objective outcome will be performance on the HVLT, while the primary, in-scanner outcomes will be behavioral and brain activation measures during performance of the N-back task.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
Cognitive Functioning [ Time Frame: 12 weeks ]
The secondary outcome variable studies changes in memory assessed using a battery of cognitive tasks.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy
Official Title  ICMJE Predictors of Healthy Mood and Memory After Oophorectomy
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 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®).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Planned RRSO
Intervention  ICMJE
  • Drug: Lisdexamfetamine
    Other Name: Vyvanse
  • Drug: Estradiol
    Other Name: Estrogen
  • Drug: Placebo
    Placebo capsules will be filled with lactose powder.
Study Arms  ICMJE
  • Active Comparator: lisdexamfetamine
    lisdexamfetamine 20 mg/d to 60 mg/d for 12 weeks
    Intervention: Drug: Lisdexamfetamine
  • Active Comparator: Estradiol
    Estradiol 1 mg/d to 3 mg/d for 12 weeks
    Intervention: Drug: Estradiol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 21, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2013)
30
Actual Study Completion Date  ICMJE July 1, 2013
Actual Primary Completion Date July 1, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Women ages 30 to 48 will be eligible for this study if they:

  1. 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;
  2. Planning to undergo an oophorectomy or full hysterectomy;
  3. Are premenopaual (have a baseline follicle stimulating hormone level (FSH) of <20 IU/ml);
  4. Smoke < 10 cigarettes per day
  5. Are right-handed;
  6. Can provide proof of having had a gynecological exam and PAP test done within the previous 3 years at the time of screening;
  7. Can provide proof of having had a mammogram within the previous 12 months at the time of screening;
  8. Are able to give written informed consent;
  9. Must have clear urine toxicology screen upon recruitment;
  10. Are fluent in written and spoken English;
  11. Negative urine pregnancy test.

Exclusion Criteria:

  1. Mini-mental status exam score of less than or equal to 24;
  2. 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;
  3. Lifetime history of drug addiction or abuse, excepting nicotine;
  4. Regular use of other psychotropic medication;
  5. Regular use (more than once a week) of alcohol that is greater than 3 drinks per day;
  6. 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;
  7. History of seizures;
  8. 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;
  9. Claustrophobia;
  10. History of cardiac disease including known cardiac defect or conduction abnormality;
  11. Abnormal electrocardiogram during screening;
  12. Current pregnancy or planning to become pregnant;
  13. Presence of a metallic implant
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 48 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01986764
Other Study ID Numbers  ICMJE 817642
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party C. Neill Epperson, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: C. Neill Epperson, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP