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Trial record 16 of 2075 for:    ESTRADIOL

Estradiol and Fear Extinction in Anorexia Nervosa (AN)

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ClinicalTrials.gov Identifier: NCT02792153
Recruitment Status : Withdrawn (The study was withdrawn after 18 months due to lack of recruitment.)
First Posted : June 7, 2016
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The purpose of this study is to determine whether estrogen may help reduce fear of high calorie-density foods in weight-restored women with Anorexia Nervosa (AN).

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: Estradiol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Estradiol and Fear Extinction for Calorie-Dense Foods in Weight Restored Adult Women With Anorexia Nervosa (AN)
Study Start Date : December 2016
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Estrogen
AN participants receive a course of transdermal estradiol treatment.
Drug: 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 Name: Climara




Primary Outcome Measures :
  1. Electrodermal skin conductance activity (EDA) during a test meal [ Time Frame: Baseline (day 1) and post-treatment (day 21) ]
    Meal-related anxiety will be estimated from EDA recordings during a 90 minute test meal session pre- and post-treatment (day 1 and day 21). EDA will be reported as the rate of peaks (>0.02 microsiemens) per second and the average skin conductance level (in microsiemens).


Secondary Outcome Measures :
  1. Heart rate variability during a test meal [ Time Frame: Baseline (day 1) and post-treatment (day 21) ]
    Variability in heart rate will be measured by the variation in interpeak (beat-to-beat) interval during the 90 minute test meal session pre- and post- treatment (day 1 and day 21).

  2. Subjective ratings of anxiety [ Time Frame: Baseline (day 1) and post-treatment (day 21) ]
    Visual analog scales will be used to assess self-report anxiety at multiple points (time 0 min, 5 min, 10 min, 20 min, 30 min, 50 min, 70 min and 90 min) during the 90 minute test meal session pre- and post-treatment (day 1 and day 21).

  3. Salivary cortisol concentration during a test meal [ Time Frame: Baseline (day 1) and post-treatment (day 21) ]
    The concentration of salivary cortisol will be assessed at multiple points (time 0 min, 5 min, 10 min, 20 min, 30 min, 50 min, 70 min and 90 min) during the test meal session. Test meals occur twice during the entire length of the study on day 1 and day 21. The cortisol response will be reported as area under the curve.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (AN):

  • Previous diagnosis of recent AN with BMI of <18.5 (within past year)
  • Current BMI > 19.0 and < 23.0 kg/m2
  • Amenorrhea or oligomenorrhea

Inclusion Criteria (Healthy Controls):

  • 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 (AN):

  • Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality
  • 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

Exclusion Criteria (Healthy Controls):

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792153


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Angela Guarda, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02792153     History of Changes
Other Study ID Numbers: IRB00030009
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Keywords provided by Johns Hopkins University:
estrogen
anxiety
amenorrhea
eating disorders
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female