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Impact of Estrogen on Fear Extinction R61

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673606
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The goal of this project is to examine how estrogen may influence the resting-state connectivity and the extinction-induced activation of the fear extinction network.

Condition or disease Intervention/treatment Phase
Fear Fear; Examination, Phobic Drug: Estradiol 2Mg Tablet Drug: Estradiol 4Mg Tablet Drug: Placebo Pills Phase 1

Detailed Description:
The aim of the study was to examine the influence of exogenous estrogen administration on the activation of the fear extinction network in women. Functional MRI data and psychophysiological indices were collected to test the influence of estrogen on women's ability to regulate conditioned fear responses. Women underwent a 3 day experimental paradigm using classical fear conditioning. The first day was conducted outside the scanner, while days 2 and 3 were done inside the fMRI scanner and tested fear extinction learning and recall in days 2 and 3, respectively. The estrogen (or placebo) pill was given just hours before extinction learning test on day 2. No followups were conducted after women completed the 3 day study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double blind placebo control study
Primary Purpose: Basic Science
Official Title: The Influence of Estrogen on the Fear Extinction Network in Humans-R61
Actual Study Start Date : January 2013
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Estradiol 2mg Dose
2mg dose of estradiol (oral administration)
Drug: Estradiol 2Mg Tablet
one 2 mg dose of estradiol (obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),
Other Name: Estrace® Tablets

Experimental: Estradiol 4mg Dose
4mg dose of estradiol (oral administration)
Drug: Estradiol 4Mg Tablet
two 2 mg pills estradiol(obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),
Other Name: Estrace® Tablets

Placebo Comparator: Placebo
placebo (oral administration)
Drug: Placebo Pills
inactive placebo pills
Other Name: Estrace® Tablets




Primary Outcome Measures :
  1. Impact of exogenous administration of estradiol on the neural correlates of fear extinction [ Time Frame: 3 Days ]
    BOLD responses during fear extinction after taking estradiol or placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right-handed (Edinburgh Inventory - Oldfield 1971).
  • SCID diagnosis consistent with none, current or past history of Axis I psychiatric disorders.
  • To be matched for age, gender, and years of education, as well as self-identified race/ethnicity.
  • For naturally cycling female subjects, stage of menstrual cycle will be ascertained by history, and by serological measures.
  • For women on oral contraceptives, we will identify those using 20mcg ethinyl, 2nd or 3rd generation, monophasic

Exclusion Criteria:

  • Psychiatric, neurologic or medical condition that would interfere with study procedures or confound results, ascertained by history.
  • History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).
  • History of Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, tic disorder, or eating disorder.
  • Use of psychotropic medication within 4 weeks prior to study (within 6 weeks for fluoxetine, or other long-lived compounds; within one year for neuroleptics).
  • Pregnancy (to be ruled out by urine ß-HCG).
  • Metallic implants or devices contraindicating magnetic resonance imaging.
  • Use of oral contraceptives or non-oral contraceptives containing estrogen and progesterone within 3 months
  • History of breast cancer.
  • Allergy to peanut oil.

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): NCT02673606


Locations
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United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Mohammed Milad, PhD NYU School of Medicine
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02673606    
Other Study ID Numbers: 2007P000496
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female