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

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flibanserin
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoactive Sexual Desire Disorder focused on measuring HSDD (Hypoactive Sexual Desire Disorder), EEG (Electroencephalogram)

Eligibility Criteria

21 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Flibanserin

Placebo

Arm Description

Drug: Flibanserin 8 weeks 100mg once daily at bedtime

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

Outcomes

Primary Outcome Measures

EEG Results: Evoked Brain Potentials (measured brain response that is the direct result of a specific cognitive event)
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

Eye movement tracking: movements to first saccades
Change from baseline eye movement tracking results at 8 weeks.

Full Information

First Posted
April 22, 2016
Last Updated
January 15, 2021
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02770768
Brief Title
Effects of Flibanserin on the Pre- and Post-menopausal Female Brain
Official Title
Flibanserin and Women With Hypoactive Sexual Desire Disorder: A Double-Blind, Randomized, Electrical Neuroimaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 21, 2021 (Anticipated)
Study Completion Date
December 21, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
HSDD (Hypoactive Sexual Desire Disorder), EEG (Electroencephalogram)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flibanserin
Arm Type
Active Comparator
Arm Description
Drug: Flibanserin 8 weeks 100mg once daily at bedtime
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)
Intervention Type
Drug
Intervention Name(s)
Flibanserin
Other Intervention Name(s)
Addyi
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
EEG Results: Evoked Brain Potentials (measured brain response that is the direct result of a specific cognitive event)
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Eye movement tracking: movements to first saccades
Description
Change from baseline eye movement tracking results at 8 weeks.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Cacioppo, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD, MPH
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21718449
Citation
Bianchi-Demicheli F, Cojan Y, Waber L, Recordon N, Vuilleumier P, Ortigue S. Neural bases of hypoactive sexual desire disorder in women: an event-related FMRI study. J Sex Med. 2011 Sep;8(9):2546-59. doi: 10.1111/j.1743-6109.2011.02376.x. Epub 2011 Jun 30.
Results Reference
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PubMed Identifier
25031302
Citation
Bolmont M, Cacioppo JT, Cacioppo S. Love is in the gaze: an eye-tracking study of love and sexual desire. Psychol Sci. 2014 Sep;25(9):1748-56. doi: 10.1177/0956797614539706. Epub 2014 Jul 16.
Results Reference
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PubMed Identifier
22353205
Citation
Cacioppo S, Bianchi-Demicheli F, Frum C, Pfaus JG, Lewis JW. The common neural bases between sexual desire and love: a multilevel kernel density fMRI analysis. J Sex Med. 2012 Apr;9(4):1048-54. doi: 10.1111/j.1743-6109.2012.02651.x. Epub 2012 Feb 21.
Results Reference
background
PubMed Identifier
26363189
Citation
Cacioppo S, Cacioppo JT. Dynamic spatiotemporal brain analyses using high-performance electrical neuroimaging, Part II: A step-by-step tutorial. J Neurosci Methods. 2015 Dec 30;256:184-97. doi: 10.1016/j.jneumeth.2015.09.004. Epub 2015 Sep 10.
Results Reference
background
PubMed Identifier
25382944
Citation
Cacioppo S, Couto B, Bolmont M, Sedeno L, Frum C, Lewis JW, Manes F, Ibanez A, Cacioppo JT. Selective decision-making deficit in love following damage to the anterior insula. Curr Trends Neurol. 2013;7:15-19.
Results Reference
background
PubMed Identifier
25244954
Citation
Cacioppo S, Weiss RM, Runesha HB, Cacioppo JT. Dynamic spatiotemporal brain analyses using high performance electrical neuroimaging: theoretical framework and validation. J Neurosci Methods. 2014 Dec 30;238:11-34. doi: 10.1016/j.jneumeth.2014.09.009. Epub 2014 Sep 20.
Results Reference
background
PubMed Identifier
18761412
Citation
Ortigue S, Bianchi-Demicheli F. The chronoarchitecture of human sexual desire: a high-density electrical mapping study. Neuroimage. 2008 Nov 1;43(2):337-45. doi: 10.1016/j.neuroimage.2008.07.059. Epub 2008 Aug 13.
Results Reference
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Effects of Flibanserin on the Pre- and Post-menopausal Female Brain

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