Effects of estrogen on eating disorders in young women
The Role of Estrogen in the Neurobiology of Eating Disorders: A Study of Cognitive Flexibility and Reward in Eating Disorders
PHASE2 · Massachusetts General Hospital · NCT03740204
This study is testing whether a hormone treatment can help young women with eating disorders feel better and change their eating habits.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 14 Years to 35 Years |
| Sex | Female |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03740204 on ClinicalTrials.gov |
What this trial studies
This interventional study investigates the impact of transdermal estradiol on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults aged 14-35 with eating disorders characterized by extreme dietary restriction and/or excessive exercise. Participants will be randomly assigned to receive either estradiol with cyclic progesterone or a placebo for 12 weeks, with assessments conducted at baseline, 8 weeks, and 12 weeks. The study includes behavioral, neuroimaging, and endocrine evaluations to understand the neurobiological role of estrogen in these conditions.
Who should consider this trial
Good fit: Ideal candidates are female adolescents and young adults aged 14-35 with clinically significant eating disorders and hypoestrogenemia.
Not a fit: Patients with eating disorders not characterized by hypoestrogenemia or those with other causes of oligo-amenorrhea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into the treatment of eating disorders by addressing hormonal imbalances in affected young women.
How similar studies have performed: While the role of estrogen in eating disorders is being explored, this specific approach using transdermal estradiol in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 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 * 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 this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Madhusmita Misra, M.D., M.P.H. — Massachusetts General Hospital
- Study coordinator: Madhusmita Misra, M.D., M.P.H.
- Email: abp6bd@uvahealth.edu
- Phone: 617-726-5790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Eating Disorders, Hypoestrogenemia, Adolescent, Amenorrhea, Anorexia Nervosa, Cognitive Flexibility, Dietary Restriction, Estrogen