The Role of Estrogen in the Neurobiology of Eating Disorders

Description

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.

Conditions

Eating Disorders, Hypoestrogenemia

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Study Overview

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Study Details

Study overview

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.

The Role of Estrogen in the Neurobiology of Eating Disorders: A Study of Cognitive Flexibility and Reward in Eating Disorders

The Role of Estrogen in the Neurobiology of Eating Disorders

Condition
Eating Disorders
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * Neurological or psychiatric disorders that may impact neural circuitry of interest
  • * Lifetime history of seizure disorder or electroconvulsive therapy
  • * Pregnancy/breastfeeding
  • * 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

Ages Eligible for Study

14 Years to 35 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Madhusmita Misra, M.D., M.P.H., PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2025-12-31