Overview

The Role of Estrogen in the Neurobiology of Eating Disorders

Status:
Recruiting
Trial end date:
2023-09-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Massachusetts General Hospital
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Estrogens
Polyestradiol phosphate
Progesterone