Estradiol and Fear Extinction in Anorexia Nervosa (AN)

• Status: Withdrawn
• Trial end date: 2018-08-22
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

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