Print

Purpose

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

Eligibility

Eligible Ages
Between 14 Years and 35 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
17-β estradiol with cyclic progesterone
  • 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)
Placebo Comparator
Placebo
  • Drug: Placebo patch and pill
    Placebo patch and pill

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Madhusmita Misra, M.D., M.P.H.
617-726-5790
mmisra@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Madhusmita Misra, M.D., M.P.H.
617-726-5790
mmisra@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.