Estradiol and Fear Extinction in Anorexia Nervosa (AN)



Status:Withdrawn
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 50
Updated:8/26/2018
Start Date:December 2016
End Date:August 22, 2018

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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).


Inclusion Criteria (AN):

- 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

Inclusion Criteria (Healthy Controls):

- 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

Exclusion Criteria (AN):

- 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)

- Allergy to estradiol or medroxyprogesterone or ingredients in food items used for test
meals

- Undiagnosed, abnormal vaginal bleeding

Exclusion Criteria (Healthy Controls):

- 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
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Phone: 410-955-3863
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