Planned RRSOE2LDXNCT01986764
E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy
A study testing Lisdexamfetamine and Estradiol in people with Planned RRSO, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Planned RRSO
- What is being tested?
- Lisdexamfetamine and Estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2013to 1 Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, 19104
About this study
Official title: Predictors of Healthy Mood and Memory After Oophorectomy
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®).
- Conditions
- Planned RRSO
- Being tested
- Lisdexamfetamine, Estradiol, Placebo
- Keywords
- oophorectomy, RRSO, menopause, early menopause, cognition, memory, brain-imaging
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisdexamfetamineDrug
Also called Vyvanse
EstradiolDrug
Also called Estrogen
PlaceboDrug
Placebo capsules will be filled with lactose powder.
| Study group | Role | What they receive |
|---|---|---|
| lisdexamfetamine | Active comparator | lisdexamfetamine 20 mg/d to 60 mg/d for 12 weeks Receives: Drug: Lisdexamfetamine |
| Estradiol | Active comparator | Estradiol 1 mg/d to 3 mg/d for 12 weeks Receives: Drug: Estradiol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BADDS Score
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.
Measured: 12 weeks
Secondary outcomes (1)
Cognitive Functioning
The secondary outcome variable studies changes in memory assessed using a battery of cognitive tasks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study start1 Jul 2013
- Primary completion1 Jul 2013
- Study completion1 Jul 2013
Why it stopped: Funding was not obtained for this study and no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Planned RRSOStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C. Neill Epperson, University of Pennsylvania
- Investigators
- C. Neill Epperson, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986764
- Sponsor's protocol ID
- 817642
- Acronym
- E2LDX
- Status last verified
- Mar 2017
- First submitted
- 30 Oct 2013
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Healthy Mood and Memory After Oophorectomy
- ClinicalTrials.gov ID
- NCT01986764
- Acronym / sponsor ID
- E2LDX / 817642
- Conditions
- Planned RRSO
- Keywords
- oophorectomy, RRSO, menopause, early menopause, cognition, memory, brain-imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not obtained for this study and no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 1 Jul 2013 (actual)
- Study completion
- 1 Jul 2013 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lisdexamfetamine | Active comparator | Drug: Lisdexamfetaminelisdexamfetamine 20 mg/d to 60 mg/d for 12 weeks |
| Estradiol | Active comparator | Drug: EstradiolEstradiol 1 mg/d to 3 mg/d for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LisdexamfetamineAlso: Vyvanse | Drug | lisdexamfetamine |
| EstradiolAlso: Estrogen | Drug | Estradiol |
| PlaceboPlacebo capsules will be filled with lactose powder. | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Cognitive Functioning
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C. Neill Epperson, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lisdexamfetamine and Estradiol in people with Planned RRSO, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BADDS Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.