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Hormone Therapy

Estrogen Therapy for Eating Disorders

Phase 2
Recruiting
Led By Madhusmita Misra, M.D., M.P.H.
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
14-35 years
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
Must not have
Lifetime history of seizure disorder or electroconvulsive therapy
Gastrointestinal tract surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is studying whether transdermal estradiol (a form of estrogen) can improve thinking skills, reward processing, and eating disorder pathology in young women with an eating disorder.

Who is the study for?
This trial is for female adolescents and young adults aged 14-35 with low estrogen levels, an eating disorder characterized by extreme dietary restriction or excessive exercise, and a high drive for thinness. Participants must not be pregnant, breastfeeding, have used estrogen treatments recently, or have any health conditions that could interfere with the study.
What is being tested?
The study tests if transdermal estradiol patches with cyclic progesterone can affect cognitive flexibility, reward processing, and eating disorder symptoms compared to placebo in participants. It's randomized and double-blind: half get real treatment; half get fake (placebo) without knowing which one they receive.
What are the potential side effects?
Potential side effects of estradiol may include nausea, headache, breast tenderness, mood swings, bloating and menstrual changes. Progesterone might cause abdominal pain or discomfort among other similar hormone-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 14 and 35 years old.
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My weight is within the normal or low range for my age.
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I have had irregular or no menstrual periods for more than 3 months.
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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures or have undergone electroconvulsive therapy.
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I have had surgery on my digestive system.
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I cannot use estrogen due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 17-β estradiol with cyclic progesteroneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,669 Total Patients Enrolled
Madhusmita Misra, M.D., M.P.H.Principal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
S.C.B. Medical College (Medical School)
Mass Gen Hospital (Residency)

Media Library

17-β estradiol transdermal patches with cyclic progesterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03740204 — Phase 2
Anorexia nervosa Research Study Groups: Placebo, 17-β estradiol with cyclic progesterone
Anorexia nervosa Clinical Trial 2023: 17-β estradiol transdermal patches with cyclic progesterone Highlights & Side Effects. Trial Name: NCT03740204 — Phase 2
17-β estradiol transdermal patches with cyclic progesterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03740204 — Phase 2
~14 spots leftby Sep 2025
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