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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights

Study 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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My bone age is at least 13.5 years old.
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I am female.

Timeline

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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,235 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you explain the typical application of 17-β estradiol transdermal patches in combination with cyclic progesterone?

"When treating amenorrhea, healthcare providers often recommend 17-β estradiol transdermal patches with cyclic progesterone. This therapy may also be used for hypoestrogenism, vasomotor symptoms associated menopause and breast cancer."

Answered by AI

To what degree is this experimental protocol open to participants?

"Affirmative. In accordance with the information on clinicaltrials.gov, this medical study is actively recruiting patients; its first announcement was published on April 13th 2019 and it has been updated most recently in November 1st 2022. The research team aims to recruit a total of 120 participants from one location."

Answered by AI

Has the FDA granted approval for 17-β estradiol transdermal patches in conjunction with cyclic progesterone?

"17-β estradiol transdermal patches with cyclic progesterone has been assessed to have a safety rating of 2 due to the lack of efficacy data from Phase 2 trials; however, prior studies do support its security."

Answered by AI

Can those aged 70 or above join this medical trial?

"This medical study is welcoming participants ranging in age from 14 to 35."

Answered by AI

Is it currently feasible to become involved in this clinical experiment?

"Per clinicaltrials.gov, this experiment is now accepting patients and has been since April 13th 2019 with its most recent update being on November 1st 2022."

Answered by AI

Could you elaborate on any previous trials that have employed a 17-β estradiol transdermal patch together with cyclic progesterone?

"Currently, 82 different clinical trials are exploring the efficacy of 17-β estradiol transdermal patches with cyclic progesterone. Of these studies, 16 have entered phase 3 and most are located in Cheras, Kuala Lumpur; however there are 986 sites across the world participating in such research."

Answered by AI

What prerequisites must be met in order to qualify for this clinical investigation?

"This clinical trial seeks 120 participants who have an eating disorder and fall between the ages of 14-35. Additionally, candidates must meet further criteria including a minimum bone age for those under 16, female gender identity, hypoestrogenemia (lack of menses), and low to normal body mass index (<85th percentile or <25kg/m2)."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
~10 spots leftby Sep 2024