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RECRUITING
NCT03740204
PHASE2

The Role of Estrogen in the Neurobiology of Eating Disorders

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

14 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2019-06-13

Completion Date

2026-12-31

Last Updated

2025-05-06

Healthy Volunteers

No

Interventions

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States