The Role of Estrogen in the Neurobiology of Eating Disorders

• Status: Recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate; Progesterone

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

• 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 intrauterine device if subject is unable to provide two to three weekly blood samples for estradiol of if estradiol levels are determined to be too high by study doctor

• Peanut allergy

• Neurological or psychiatric disorders that may impact neural circuitry of interest

• Lifetime history of seizure disorder or electroconvulsive therapy

• Pregnancy/breastfeeding

• Contraindications to MRI

• Gastrointestinal tract surgery

• Contraindications to estrogen use

• Any other significant illness or condition that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk