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

The University of Chicago

Status: Terminated

Conditions: Hypoactive Sexual Desire Disorder

Treatments: Drug: Flibanserin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02770768

IRB16-0087

Details and patient eligibility

About

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).

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 21 to 74 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups, including a placebo group

Flibanserin

Active Comparator group

Description:

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

Treatment:

Drug: Flibanserin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo