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

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ClinicalTrials.gov Identifier: NCT02770768
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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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
Hypoactive Sexual Desire Disorder Drug: Flibanserin Drug: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2016
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Flibanserin

Arms and Interventions
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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 Name: 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 Name: Matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. EEG Results: Evoked Brain Potentials (measured brain response that is the direct result of a specific cognitive event) [ Time Frame: 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 [ Time Frame: 8 weeks ]
    Change from baseline eye movement tracking results at 8 weeks.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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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): NCT02770768


Contacts
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Contact: Erika Kaske 773-834-5264 ekaske@yoda.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Erika Kaske    773-834-5264    ekaske@yoda.bsd.uchicago.edu   
Contact: Stephanie Cacioppo, PhD    773-702-6983    scacioppo@yoda.bsd.uchicago.edu   
Principal Investigator: Stephanie Cacioppo, PhD         
Sub-Investigator: Jon E Grant, JD, MD, MPH         
Sub-Investigator: Royce Lee, MD         
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Stephanie Cacioppo, PhD University of Chicago
Principal Investigator: Jon E Grant, MD, JD, MPH University of Chicago
More Information
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Publications:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02770768     History of Changes
Other Study ID Numbers: IRB16-0087
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Chicago:
HSDD (Hypoactive Sexual Desire Disorder)
EEG (Electroencephalogram)
Additional relevant MeSH terms:
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Hypokinesia
Sexual Dysfunctions, Psychological
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Mental Disorders