The Role of Estrogen in the Neurobiology of Eating Disorders
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Eating Disorders, Hypoestrogenemia
In brief
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.
Key facts
- Study ID
- NCT03740204
- Run by
- Massachusetts General Hospital
- People needed
- 120
- Starts
- 2019-06-13
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-05-29
Who can join
Age: 14 and older, up to 35. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- 14-35 years
- Bone age ≥13.5 years (applicable only for participants <16 years)
- Clinically significant eating disorder characterized by restriction and/or excessive exercise and high drive for thinness
- Hypoestrogenemia: Oligo-amenorrhea defined as lack of menses for ≥3 months within a 6-month period of oligomenorrhea (cycle length ≥5 weeks) or absence of menses at >15 years if premenarchal or low estradiol levels evaluated by the study physician
- Low or normal weight defined by a body mass index that is <85th percentile for 14-18 year olds and a body mass index <25 kg/m2 for adults
You may not qualify if…
- Suicidal ideation where outpatient treatment is determined unsafe by study clinician
- Other causes of oligo-amenorrhea, unless a study clinician determines that missed menstrual periods are more likely a consequence of restrictive eating
- Medications that contain estrogen ± progesterone within the past 3 months
- Levonorgestrel-releasing intrauterine device if subject is unable to provide two to three weekly blood samples for estradiol of if estradiol levels are determined to be too high by study doctor
- Neurological or psychiatric disorders that may impact neural circuitry of interest
- Lifetime history of seizure disorder or electroconvulsive therapy
- Pregnancy/breastfeeding
- Gastrointestinal tract surgery
- Contraindications to estrogen use
- Any other significant illness or condition that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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