E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy (E2LDX)
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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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Planned RRSO | Drug: Lisdexamfetamine Drug: Estradiol Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Predictors of Healthy Mood and Memory After Oophorectomy |
Actual Study Start Date : | July 1, 2013 |
Actual Primary Completion Date : | July 1, 2013 |
Actual Study Completion Date : | July 1, 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: lisdexamfetamine
lisdexamfetamine 20 mg/d to 60 mg/d for 12 weeks
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Drug: Lisdexamfetamine
Other Name: Vyvanse |
Active Comparator: Estradiol
Estradiol 1 mg/d to 3 mg/d for 12 weeks
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Drug: Estradiol
Other Name: Estrogen |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo capsules will be filled with lactose powder. |
- 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.
- Cognitive Functioning [ Time Frame: 12 weeks ]The secondary outcome variable studies changes in memory assessed using a battery of cognitive tasks.

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Ages Eligible for Study: | 30 Years to 48 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Women ages 30 to 48 will be eligible for this study if they:
- 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;
- 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;
- Must have clear urine toxicology screen upon recruitment;
- Are fluent in written and spoken English;
- Negative urine pregnancy test.
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;
- Claustrophobia;
- History of cardiac disease including known cardiac defect or conduction abnormality;
- Abnormal electrocardiogram during screening;
- Current pregnancy or planning to become pregnant;
- Presence of a metallic implant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986764
United States, Pennsylvania | |
Penn Center for Women's Behavioral Wellness | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | C. Neill Epperson, MD | University of Pennsylvania |
Responsible Party: | C. Neill Epperson, Associate Professor of Psychiatry, University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01986764 |
Other Study ID Numbers: |
817642 |
First Posted: | November 18, 2013 Key Record Dates |
Last Update Posted: | March 24, 2017 |
Last Verified: | March 2017 |
oophorectomy RRSO menopause early menopause |
cognition memory brain-imaging |
Lisdexamfetamine Dimesylate Estradiol Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Central Nervous System Stimulants |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |