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Estrogen Therapy for Eating Disorders
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am between 14 and 35 years old.I have a neurological or psychiatric condition that affects my brain's functioning.You are not experiencing a lack of menstrual periods due to factors other than restricted eating, unless a study doctor determines that it is the cause.My weight is within the normal or low range for my age.You are pregnant or breastfeeding.You have another health condition that could affect your safety or make it difficult for you to participate in the study.I have had irregular or no menstrual periods for more than 3 months.My bone age is at least 13.5 years old.I use a levonorgestrel IUD because I can't give frequent blood samples or my estrogen levels are too high.I have not taken estrogen or progesterone medications in the last 3 months.I have a history of seizures or have undergone electroconvulsive therapy.You have an allergy to peanuts.You cannot have an MRI scan due to medical reasons.I have had surgery on my digestive system.You have a serious eating disorder that includes extreme dieting, excessive exercising, and an obsession with being thin.I cannot use estrogen due to health reasons.I am female.
- Group 1: Placebo
- Group 2: 17-β estradiol with cyclic progesterone
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Can those aged 70 or above join this medical trial?
"This medical study is welcoming participants ranging in age from 14 to 35."
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."
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."
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)."
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What portion of applicants met pre-screening criteria?
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