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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 baseline to 12 weeks

Awards & highlights

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in EDI-3 Drive for Thinness score (Range: 0-28; direction: Higher values indicate more pronounced drive for thinness/worse outcome) with 17-β estradiol versus placebo

Change in Eating Disorder Inventory-3 (EDI-3) Body Dissatisfaction score (Range: 0-36; direction: Higher values indicate more pronounced body dissatisfaction/worse outcome) with 17-β estradiol versus placebo

Change in Temporal Experience of Pleasure Scale (TEPS) Consummatory Pleasure score (Range: 8-48; direction: Higher values indicate more pronounced consummatory pleasure/better outcome) with 17-β estradiol versus placebo

+2 more

Secondary outcome measures

Change in caloric intake by 4-day food diary with 17-β estradiol versus placebo

Ventral Striatum

Change in fMRI activation of the ventromedial prefrontal cortex (VMPFC) and ventral striatum in response to reward receipt with 17-β estradiol versus placebo

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 17-β estradiol with cyclic progesteroneExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,955 Previous Clinical Trials

13,212,558 Total Patients Enrolled

5 Trials studying Eating Disorders

455 Patients Enrolled for Eating Disorders

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

Eating Disorders Research Study Groups: Placebo, 17-β estradiol with cyclic progesterone

Eating Disorders 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

~22 spots leftby Sep 2025

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