Overview

The Role of Estrogen in the Neurobiology of Eating Disorders

Status:
Recruiting
Trial end date:
2023-09-30
Target enrollment:
0
Participant gender:
Female
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Massachusetts General Hospital
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Estrogens
Polyestradiol phosphate
Progesterone
Criteria
Inclusion criteria:

- 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

- 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

Exclusion criteria:

- 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

- Peanut allergy

- Neurological or psychiatric disorders that may impact neural circuitry of interest

- Lifetime history of seizure disorder or electroconvulsive therapy

- Pregnancy/breastfeeding

- Contraindications to MRI

- 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