Actively Recruiting
The Role of Estrogen in the Neurobiology of Eating Disorders
Led by Massachusetts General Hospital · Updated on 2025-05-06
120
Participants Needed
1
Research Sites
394 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Role of Estrogen in the Neurobiology of Eating Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age between 14 and 35 years
- Bone age at least 13.5 years (for participants under 16 years old)
- Clinically significant eating disorder with restriction and/or excessive exercise and high drive for thinness
- Hypoestrogenemia defined as oligo-amenorrhea (lack of menses for 3 or more months within 6 months) or absence of menses by age 15 if premenarchal or low estradiol levels
- Low or normal weight: BMI below 85th percentile for ages 14-18 or BMI below 25 kg/m2 for adults
You will not qualify if you...
- Suicidal thoughts deemed unsafe for outpatient treatment
- Other causes of oligo-amenorrhea unless due to restrictive eating as determined by study clinician
- Use of estrogen or progesterone medications within past 3 months
- Use of levonorgestrel intrauterine device if unable to provide required blood samples or estradiol levels too high
- Neurological or psychiatric disorders affecting brain circuits under study
- History of seizures or electroconvulsive therapy
- Pregnancy or breastfeeding
- Previous gastrointestinal surgery
- Contraindications to estrogen use
- Any other significant illness or condition that could interfere with participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
M
Madhusmita Misra, M.D., M.P.H.
CONTACT
K
Kamryn Eddy, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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