NCT02673606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

6.3 years

First QC Date

January 26, 2016

Last Update Submit

July 29, 2020

Conditions

FearFear; Examination, Phobic

Outcome Measures

Primary Outcomes (1)

  • Impact of exogenous administration of estradiol on the neural correlates of fear extinction

    BOLD responses during fear extinction after taking estradiol or placebo

    3 Days

Study Arms (3)

Estradiol 2mg Dose

EXPERIMENTAL

2mg dose of estradiol (oral administration)

Drug: Estradiol 2Mg Tablet

Estradiol 4mg Dose

EXPERIMENTAL

4mg dose of estradiol (oral administration)

Drug: Estradiol 4Mg Tablet

Placebo

PLACEBO COMPARATOR

placebo (oral administration)

Drug: Placebo Pills

Interventions

Estradiol 2Mg TabletDRUG

one 2 mg dose of estradiol (obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),

Also known as: Estrace® Tablets
Estradiol 2mg Dose
Estradiol 4Mg TabletDRUG

two 2 mg pills estradiol(obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),

Also known as: Estrace® Tablets
Estradiol 4mg Dose
Placebo PillsDRUG

inactive placebo pills

Also known as: Estrace® Tablets
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

EstradiolTablets

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsDosage FormsPharmaceutical Preparations

Study Officials

  • Mohammed Milad, PhD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blind placebo control study
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 4, 2016

Study Start

January 1, 2013

Primary Completion

April 15, 2019

Study Completion

April 15, 2019

Last Updated

July 30, 2020

Record last verified: 2020-07

Locations

US(1)