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The Role of Estrogen in the Neurobiology of Eating Disorders

NCT03740204 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Madhusmita Misra, M.D., M.P.H. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2026-09-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03740204 on ClinicalTrials.gov