NCT03740204

The Role of Estrogen in the Neurobiology of Eating Disorders

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 14 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eating Disorders
• Hypoestrogenemia

Interventions

Type	Name	Description
DRUG	17-β estradiol transdermal patches with cyclic progesterone	17-β estradiol transdermal patches (100 mcg 17-β estradiol/day) with cyclic progesterone (200 mg micronized progesterone daily for 12 days every month)
DRUG	Placebo patch and pill	Placebo patch and pill

Timeline

• Start date: 2019-06-13
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2018-11-14
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study