The Role of Estrogen in the Neurobiology of Eating Disorders

Phase 2

Recruiting

• Conditions: Eating Disorders; Hypoestrogenemia
• Interventions: Drug: 17-β estradiol transdermal patches with cyclic progesterone; Drug: Placebo patch and pill

• Registration Number: NCT03740204
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-14
• Study Start: 2019-06-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
17-β estradiol with cyclic progesterone	17-β estradiol transdermal patches with cyclic progesterone	-
Placebo	Placebo patch and pill	-

Primary Outcome Measures

Name	Time	Method
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	Baseline 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 placebo	Baseline to 8 weeks
Change in delay discounting parameter k using the Monetary Choice Questionnaire with 17-β estradiol versus placebo	Baseline 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 placebo	Baseline 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 placebo	Baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in functional magnetic resonance imaging (fMRI) activation of the dorsolateral prefrontal cortex (DLPFC) and anterior cingulate cortex (ACC) during a task switching paradigm with 17-β estradiol versus placebo	Baseline to 8 weeks
Change in caloric intake by 4-day food diary with 17-β estradiol versus placebo	Baseline to 12 weeks
Change in the Eating Disorder Examination (EDE) Dietary Restraint subscale (Range: 0-6; direction: Higher values indicate more pronounced dietary restraint/worse outcome) with 17-β estradiol versus placebo	Baseline to 12 weeks
Change in fMRI activation of the ventromedial prefrontal cortex (VMPFC) and ventral striatum in response to reward receipt with 17-β estradiol versus placebo	Baseline to 8 weeks
Change in fMRI activation of the VMPFC and ventral striatum during delay discounting with 17-β estradiol versus placebo	Baseline to 8 weeks

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States