The Role of Estrogen in the Neurobiology of Eating Disorders

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.

Timeline

Start

2019-06-13

Primary completion

2025-12-30

Completion

2026-12-31

Publications

• Breithaupt L, Slattery M, Lauze M, Petterway F, Lindman L, Cravitz M, Naticchia S, Seenivasa S, Powers M, Javaras KN, Alperovitz DJ, Halperin J, Dechant E, Thomas JJ, Lawson EA, Lee H, Pizzagalli DA, Romer AL, Kumar P, Plessow F, Misra M, Eddy KT. Study protocol for a randomized, placebo-controlled, double-masked mechanistic clinical trial of transdermal estrogen replacement in hypoestrogenic eating disorders to explore the role of estrogen on cognitive flexibility and reward processing. Contemp Clin Trials. 2025 Jul;154:107924. doi: 10.1016/j.cct.2025.107924. Epub 2025 Apr 26.

Drugs

Indications