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NCT03740204

The Role of Estrogen in the Neurobiology of Eating Disorders

Active, Not Recruiting
PHASE2Ages 14–35InterventionalTreatment
Massachusetts General Hospital
~120 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:17-β estradiol transdermal patches with cyclic progesteronePlacebo patch and pill

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in inhibition-switching performance on the Delis-Kaplan Executive Function System Color-Word Interference Test (D-KEFS CWIT) with 17-β estradiol versus placebo
Measured over Baseline to 8 weeks
+4 more outcomes measured

Conditions

Eating Disorders
Hypoestrogenemia

Explore related trials

Anorexia NervosaEating Disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in inhibition-switching performance on the Delis-Kaplan Executive Function System Color-Word Interference Test (D-KEFS CWIT) with 17-β estradiol versus placeboBaseline to 8 weeks
  • Change in Temporal Experience of Pleasure Scale (TEPS) Consummatory Pleasure score (Range: 8-48; direction: Higher values indicate more pronounced consummatory pleasure/better outcome) with 17-β estradiol versus placeboBaseline to 8 weeks
  • Change in delay discounting parameter k using the Monetary Choice Questionnaire with 17-β estradiol versus placeboBaseline to 8 weeks
  • Change in Eating Disorder Inventory-3 (EDI-3) Body Dissatisfaction score (Range: 0-36; direction: Higher values indicate more pronounced body dissatisfaction/worse outcome) with 17-β estradiol versus placeboBaseline to 12 weeks
  • Change in EDI-3 Drive for Thinness score (Range: 0-28; direction: Higher values indicate more pronounced drive for thinness/worse outcome) with 17-β estradiol versus placeboBaseline to 12 weeks