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

• Status: Active, not recruiting
• Trial end date: 2021-12-21
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago

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