The Role of Estrogen in the Neurobiology of Eating Disorders

Last updated: May 2, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Mood Disorders

Treatment

17-β estradiol transdermal patches with cyclic progesterone

Placebo patch and pill

Clinical Study ID

NCT03740204
1R01MH116205
  • Ages 14-35
  • Female

Study 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

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 excessiveexercise 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 >15years 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 14-18year olds and a body mass index <25 kg/m2 for adults

Exclusion

Exclusion criteria:

  • Suicidal ideation where outpatient treatment is determined unsafe by study clinician

  • Other causes of oligo-amenorrhea, unless a study clinician determines that missedmenstrual 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 tothree weekly blood samples for estradiol of if estradiol levels are determined to betoo 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 couldinterfere with study participation or safety or put the subject at any unnecessaryrisk

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: 17-β estradiol transdermal patches with cyclic progesterone
Phase: 2
Study Start date:
June 13, 2019
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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