The Role of Estrogen in the Neurobiology of Eating Disorders
Trial Parameters
Brief Summary
This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments.
Eligibility Criteria
Inclusion criteria: * Female * 14-35 years * Bone age ≥13.5 years (applicable only for participants \<16 years) * Clinically significant eating disorder characterized by restriction and/or excessive exercise and high drive for thinness * Hypoestrogenemia: Oligo-amenorrhea defined as lack of menses for ≥3 months within a 6-month period of oligomenorrhea (cycle length ≥5 weeks) or absence of menses at \>15 years if premenarchal or low estradiol levels evaluated by the study physician * Low or normal weight defined by a body mass index that is \<85th percentile for 14-18 year olds and a body mass index \<25 kg/m2 for adults Exclusion criteria: * Suicidal ideation where outpatient treatment is determined unsafe by study clinician * Other causes of oligo-amenorrhea, unless a study clinician determines that missed menstrual periods are more likely a consequence of restrictive eating * Medications that contain estrogen ± progesterone within the past 3 months * Levonorgestrel-releasing intraut