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Transdermal Estrogen for Anorexia Nervosa
Study Summary
This trial looks at whether using estrogen can help with low bone mass in women with anorexia nervosa.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ 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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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
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- I or my close family member had breast cancer.The T-score of your bone scan is less than -1.0 at spine or hip.I have been diagnosed with anorexia nervosa.I have had a stroke or heart attack in the past.I do not have conditions like untreated thyroid issues, vitamin D deficiency, Cushing's syndrome, diabetes, or severe kidney problems.I have a history of hereditary angioedema.You have stopped having menstrual periods.I have a history of blood clotting disorders.You have stopped menstruating.I am female.I am between 19 and 45 years old.I have had a blood clot in my veins or arteries before.I am between 19 and 45 years old.You are currently addicted to drugs or alcohol.I haven't taken any medications that affect bone health in the specified time frames.I have had a bone fracture in the last year.I am female.I have been diagnosed with anorexia nervosa.
- Group 1: Placebo
- Group 2: Transdermal estrogen/progesterone
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 18 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this study allow for elderly participants?
"The age limit for this clinical trial is set at 45 years old. If you are younger than 19 or older than 44, there are other ongoing studies (44 for people under 18 and 53 for seniors) that might be a better fit."
Could I possibly be a candidate for this research project?
"Currently, this anorexia nervosa study is looking for 66 female patients aged between 19-45 years old that meet the DSM-5 psychiatric criteria for anorexia nervosa. Furthermore, these individuals must have a T-score of -1.0 or lower at the hip or spine and amenorrhea. Lastly, candidates must not exceed 85% of their ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables"
Why is Transdermal estrogen commonly given to patients?
"Transdermal estrogen is most commonly used to treat amenorrhea, or the absence of a menstrual period, in women who have not menstruated for at least 6 months. It can also be used to alleviate other conditions like hypoestrogenism and menopausal vasomotor symptoms."
How large is the sample size for this research project?
"That is accurate. The clinicaltrials.gov website contains information confirming that this study, which was first posted on 8/28/2020, is still recruiting patients. 66 individuals are needed at a single site for the trial."
Has Transdermal estrogen received government sanctioning?
"Transdermal estrogen received a 2 for safety. This is due to the fact that it is still in Phase 2 trials, meaning that while there are studies supporting its safety, none have been done yet to show if it effective."
Is this study still looking for participants?
"The trial is still recruiting patients, as seen on clinicaltrials.gov. The listing for this experiment was first put up on August 28th 2020 and has been updated as recently as May 5th 2022."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- University of Pittsburgh School of Medicine: < 48 hours
Average response time
- < 2 Days
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