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

Not Applicable

Terminated

• Conditions: Hypoactive Sexual Desire Disorder
• Interventions: Drug: Flibanserin; Drug: Placebo

• Registration Number: NCT02770768
• Lead Sponsor: University of Chicago

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Study Start: 2016-10
• Primary Completion: 2021-12-21
• Study Completion: 2021-12-21
• Results First Submitted: 2023-04-13
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Results First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flibanserin	Flibanserin	Drug: Flibanserin * 8 weeks * 100mg once daily at bedtime
Placebo	Placebo	Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Eye Movement Tracking: Movements to First Saccades	8 weeks	Change from baseline eye movement tracking results at 8 weeks.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States