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Effects of Flibanserin on the Pre- and Post-menopausal Female Brain

Sponsor
University of Chicago (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02770768
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
62.7
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the present study is to understand the neurobiological mechanisms of action underlying sexual desire building on prior work Dr. Stephanie Cacioppo has done in which desire was not manipulated. In the present project, Dr. Stephanie Cacioppo is manipulating desire through Flibanserin (Addyi) vs. placebo and she will be measuring subjective sexual desire as a manipulation check. The investigators will address this goal using a double-blind randomized outpatient design and determine the pre-post neurobehavioral change in the Flibanserin group and investigate the extent to which Flibanserin normalizes brain activity in premenopausal women with HSDD and the extent to which regional brain activation is associated with changes in symptoms and behavior (as measured with self-report measures of sexual desire and/or eye-tracking movements).

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Hypoactive sexual desire disorder (HSDD) is the most common sexual complaint in women. Over the past 8 years, Dr. Stephanie Cacioppo has developed and validated the Desire Intention task, in which individuals are instructed to indicate as rapidly and as accurately as possible whether or not each visually presented stimulus (e.g., attractive persons of the opposite sex) is sexually desirable to them at the moment of the experiment. Flibanserin (Addyi) is a new medication approved by the FDA for the treatment of HSDD in pre-menopausal women. The investigators propose a study using the DIT to determine the extent to which Flibanserin normalizes brain activity in women with HSDD and the extent to which regional brain activation is associated with changes in symptoms and behavior.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Flibanserin and Women With Hypoactive Sexual Desire Disorder: A Double-Blind, Randomized, Electrical Neuroimaging Study
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Dec 21, 2021
Anticipated Study Completion Date :
Dec 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Flibanserin

Drug: Flibanserin 8 weeks 100mg once daily at bedtime

Drug: Flibanserin
Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.
Other Names:
  • Addyi

    		•
    Placebo Comparator: Placebo

    Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)

    Drug: Placebo
    Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.
    Other Names:
  • Matching placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. EEG Results: Evoked Brain Potentials (measured brain response that is the direct result of a specific cognitive event) [8 weeks]

      Change from baseline EEG results at 8 weeks. Average the electrical brain activity evoked by each type of stimuli to calculate the evoked brain potentials (any stereotyped electrophysical response to a stimulus).

    Secondary Outcome Measures

    1. Eye movement tracking: movements to first saccades [8 weeks]

      Change from baseline eye movement tracking results at 8 weeks.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 74 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female

    • Ages 21-45 or 51-74

    • Pre- or Postmenopausal

    • DSM-5 diagnosis of hypoactive sexual desire disorder (HSDD)

    • Right-handed

    Exclusion Criteria:

    • Male

    • Pregnant women

    • Nursing women

    • Post-menopausal women

    • Women who report not being able to stop drinking alcohol during the duration of the study

    • Currently taking psychotropic medication

    • History of seizures or neurological disorders

    • Under hormonal therapy

    • Current or past diagnosis of cancer

    • Any unstable medical illnesses

    • Lifetime history of bipolar disorder, schizophrenia, or psychotic disorder

    • Current or recent (past 3 months) substance abuse or dependence

    • Current or recent (past 3 months) clinical depression

    • Currently taking any medications that have/may have unfavorable interactions with Flibanserin

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago

    Investigators

    • Principal Investigator: Stephanie Cacioppo, PhD, University of Chicago
    • Principal Investigator: Jon E Grant, MD, JD, MPH, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT02770768
    Other Study ID Numbers:
    • IRB16-0087
    First Posted:
    May 12, 2016
    Last Update Posted:
    Jan 19, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University of Chicago
    HSDD (Hypoactive Sexual Desire Disorder)
    EEG (Electroencephalogram)
    Additional relevant MeSH terms:
    Hypokinesia
    Sexual Dysfunctions, Psychological

    Study Results

    No Results Posted as of Jan 19, 2021