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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Flibanserin and Women With Hypoactive Sexual Desire Disorder: A Double-Blind, Randomized, Electrical Neuroimaging Study

Conditions
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Hypoactive Sexual Desire Disorder

Intervention / Treatment
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* Drug: Flibanserin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flibanserin<br>Drug: Flibanserin 8 weeks 100mg once daily at bedtime | Drug: Flibanserin<br>* 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.<br>* Other names: Addyi;|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>* Other names: Matching placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye movement tracking: movements to first saccades | Change from baseline eye movement tracking results at 8 weeks. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSDD (Hypoactive Sexual Desire Disorder), EEG (Electroencephalogram)