NCT02770768

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).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 22, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 16, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

5.2 years

First QC Date

April 22, 2016

Results QC Date

April 13, 2023

Last Update Submit

May 6, 2024

Conditions

Hypoactive Sexual Desire Disorder

Keywords

HSDD (Hypoactive Sexual Desire Disorder)EEG (Electroencephalogram)

Outcome Measures

Primary Outcomes (1)

  • 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).

    8 weeks

Secondary Outcomes (1)

  • Eye Movement Tracking: Movements to First Saccades

    8 weeks

Study Arms (2)

Flibanserin

ACTIVE COMPARATOR

Drug: Flibanserin * 8 weeks * 100mg once daily at bedtime

Drug: Flibanserin

Placebo

PLACEBO COMPARATOR

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

Interventions

FlibanserinDRUG

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.

Also known as: Addyi
Flibanserin
PlaceboDRUG

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.

Also known as: Matching placebo
Placebo

Eligibility Criteria

Age21 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Ages 21-45 or 51-74
  • Pre- or Postmenopausal
  • DSM-5 diagnosis of hypoactive sexual desire disorder (HSDD)
  • Right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (7)

  • 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.

    PMID: 21718449BACKGROUND

  • 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.

    PMID: 25031302BACKGROUND

  • 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.

    PMID: 22353205BACKGROUND

  • 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.

    PMID: 26363189BACKGROUND

  • 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.

    PMID: 25382944BACKGROUND

  • 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.

    PMID: 25244954BACKGROUND

  • 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.

    PMID: 18761412BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

flibanserin

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Compliance Specialist
Organization
University of Chicago
czwieg@bsd.uchicago.edu
773-702-6505

Study Officials

  • Stephanie Cacioppo, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

  • Jon E Grant, MD, JD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2016

First Posted

May 12, 2016

Study Start

October 1, 2016

Primary Completion

December 21, 2021

Study Completion

December 21, 2021

Last Updated

May 16, 2024

Results First Posted

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)