Anorexia NervosaPhase 1NCT02792153
Estradiol and Fear Extinction in Anorexia Nervosa (AN)
A Phase 1 study testing Estradiol in people with Anorexia Nervosa, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether estrogen may help reduce fear of high calorie-density foods in weight-restored women with Anorexia Nervosa (AN). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 22 Aug 2018
- Phase
- Phase 1
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Previous diagnosis of recent AN with BMI of <18.5 (within past year)
- Current BMI > 19.0 and < 23.0 kg/m2
- Amenorrhea or oligomenorrhea
- BMI > 19 < 23 kg/m2
- Taking hormone-based contraceptives for a period of one month or more
- Eating disorders symptom scores within one standard deviation of healthy controls
Who cannot join
- Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality
- History of breast cancer, deep vein thrombosis, pulmonary embolism, myocardial infarction or stroke, diabetes, liver disease, known thrombophilic disease
- Currently taking estrogen or progesterone medication
- Tobacco use greater than 1 pack per week
- Use of St. John's Wort, Phenobarbital, phenytoin, carbamazepine, rifampin, and dexamethasone can all decrease plasma estrogen level because they are CYP3A4 inducers. Cimetidine, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice as these may increase plasma estrogen, potentially increasing the presence of side effects
- Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks)
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- Allergy to estradiol or medroxyprogesterone or ingredients in food items used for test meals
- Undiagnosed, abnormal vaginal bleeding
- Ever diagnosed with an Eating Disorder
- Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality
- Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks)
- Food allergies to items in the test meal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estradiol and Fear Extinction for Calorie-Dense Foods in Weight Restored Adult Women With Anorexia Nervosa (AN)
The purpose of this study is to determine whether estrogen may help reduce fear of high calorie-density foods in weight-restored women with Anorexia Nervosa (AN).
- Conditions
- Anorexia Nervosa
- Being tested
- Estradiol
- Keywords
- estrogen, anxiety, amenorrhea, eating disorders
- Medical subject headings
- Anorexia Nervosa, Anxiety Disorders, Amenorrhea, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
Also called Climara
AN participants will be prescribed 28 days of transdermal estradiol 0.1 mg/d (Days 1-28) plus 10 days (days 21-31) oral medroxyprogesterone 2.5 mg/d.
| Study group | Role | What they receive |
|---|---|---|
| Estrogen | Experimental | AN participants receive a course of transdermal estradiol treatment. Receives: Drug: Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrodermal skin conductance activity (EDA) during a test meal
Meal-related anxiety will be estimated from EDA recordings during a 90 minute test meal session pre- and post-treatment (day 1 and day 21). EDA will be reported as the rate of peaks (>0.02 microsiemens) per second and the average skin conductance level (in microsiemens).
Measured: Baseline (day 1) and post-treatment (day 21)
Secondary outcomes (3)
Heart rate variability during a test meal
Variability in heart rate will be measured by the variation in interpeak (beat-to-beat) interval during the 90 minute test meal session pre- and post- treatment (day 1 and day 21).
Measured: Baseline (day 1) and post-treatment (day 21)
Subjective ratings of anxiety
Visual analog scales will be used to assess self-report anxiety at multiple points (time 0 min, 5 min, 10 min, 20 min, 30 min, 50 min, 70 min and 90 min) during the 90 minute test meal session pre- and post-treatment (day 1 and day 21).
Measured: Baseline (day 1) and post-treatment (day 21)
Salivary cortisol concentration during a test meal
The concentration of salivary cortisol will be assessed at multiple points (time 0 min, 5 min, 10 min, 20 min, 30 min, 50 min, 70 min and 90 min) during the test meal session. Test meals occur twice during the entire length of the study on day 1 and day 21. The cortisol response will be reported as area under the curve.
Measured: Baseline (day 1) and post-treatment (day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startDec 2016
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Why it stopped: The study was withdrawn after 18 months due to lack of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Guarda, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792153
- Sponsor's protocol ID
- IRB00030009
- Status last verified
- Aug 2018
- First submitted
- 23 May 2016
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estradiol and Fear Extinction for Calorie-Dense Foods in Weight Restored Adult Women With Anorexia Nervosa (AN)
- ClinicalTrials.gov ID
- NCT02792153
- Acronym / sponsor ID
- IRB00030009
- Conditions
- Anorexia Nervosa
- Keywords
- estrogen, anxiety, amenorrhea, eating disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn after 18 months due to lack of recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 7 Jun 2016 (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.
The purpose of this study is to determine whether estrogen may help reduce fear of high calorie-density foods in weight-restored women with Anorexia Nervosa (AN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Estrogen | Experimental | Drug: EstradiolAN participants receive a course of transdermal estradiol treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Previous diagnosis of recent AN with BMI of <18.5 (within past year)
- Current BMI > 19.0 and < 23.0 kg/m2
- Amenorrhea or oligomenorrhea
- BMI > 19 < 23 kg/m2
- Taking hormone-based contraceptives for a period of one month or more
Key exclusion criteria (12 listed)
- Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality
- History of breast cancer, deep vein thrombosis, pulmonary embolism, myocardial infarction or stroke, diabetes, liver disease, known thrombophilic disease
- Currently taking estrogen or progesterone medication
- Tobacco use greater than 1 pack per week
- Use of St. John's Wort, Phenobarbital, phenytoin, carbamazepine, rifampin, and dexamethasone can all decrease plasma estrogen level because they are CYP3A4 inducers. Cimetidine, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice as these may increase plasma estrogen, potentially increasing the presence of side effects
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 |
|---|---|---|
| EstradiolAlso: ClimaraAN participants will be prescribed 28 days of transdermal estradiol 0.1 mg/d (Days 1-28) plus 10 days (days 21-31) oral medroxyprogesterone 2.5 mg/d. | Drug | Estrogen |
Primary outcome
Electrodermal skin conductance activity (EDA) during a test meal
Time frame: Baseline (day 1) and post-treatment (day 21)
Meal-related anxiety will be estimated from EDA recordings during a 90 minute test meal session pre- and post-treatment (day 1 and day 21). EDA will be reported as the rate of peaks (>0.02 microsiemens) per second and the average skin conductance level (in microsiemens).
3 secondary outcomes
Heart rate variability during a test meal
Time frame: Baseline (day 1) and post-treatment (day 21)
Subjective ratings of anxiety
Time frame: Baseline (day 1) and post-treatment (day 21)
Salivary cortisol concentration during a test meal
Time frame: Baseline (day 1) and post-treatment (day 21)
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 Aug 2018.
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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.
Angela Guarda, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Estradiol in people with Anorexia Nervosa, run by Johns Hopkins University 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 6 inclusion and 12 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 Aug 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Electrodermal skin conductance activity (EDA) during a test meal (time frame: Baseline (day 1) and post-treatment (day 21)). 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 Aug 2018.