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Recruitment Status : Withdrawn (Funding was not obtained for this study and no participants were enrolled.)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
|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|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Active Comparator: lisdexamfetamine
lisdexamfetamine 20 mg/d to 60 mg/d for 12 weeks
Other Name: Vyvanse
Active Comparator: Estradiol
Estradiol 1 mg/d to 3 mg/d for 12 weeks
Other Name: Estrogen
|Placebo Comparator: 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.
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|