Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2016-12-31
2018-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Estrogen
AN participants receive a course of transdermal estradiol treatment.
Estradiol
AN participants will be prescribed 28 days of transdermal estradiol 0.1 mg/d (Days 1-28) plus 10 days (days 21-31) oral medroxyprogesterone 2.5 mg/d.
Interventions
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Estradiol
AN participants will be prescribed 28 days of transdermal estradiol 0.1 mg/d (Days 1-28) plus 10 days (days 21-31) oral medroxyprogesterone 2.5 mg/d.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current BMI \> 19.0 and \< 23.0 kg/m2
* Amenorrhea or oligomenorrhea
* BMI \> 19 \< 23 kg/m2
* Taking hormone-based contraceptives for a period of one month or more
* Eating disorders symptom scores within one standard deviation of healthy controls
Exclusion Criteria
* History of breast cancer, deep vein thrombosis, pulmonary embolism, myocardial infarction or stroke, diabetes, liver disease, known thrombophilic disease
* Currently taking estrogen or progesterone medication
* Tobacco use greater than 1 pack per week
* Use of St. John's Wort, Phenobarbital, phenytoin, carbamazepine, rifampin, and dexamethasone can all decrease plasma estrogen level because they are CYP3A4 inducers. Cimetidine, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice as these may increase plasma estrogen, potentially increasing the presence of side effects
* Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks)
* Allergy to estradiol or medroxyprogesterone or ingredients in food items used for test meals
* Undiagnosed, abnormal vaginal bleeding
* Ever diagnosed with an Eating Disorder
* Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality
* Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks)
* Food allergies to items in the test meal
18 Years
50 Years
FEMALE
Yes
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Angela Guarda, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00030009
Identifier Type: -
Identifier Source: org_study_id
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