An interventional study of Flibanserin and Placebo in Hypoactive Sexual Desire Disorder, sponsored by University of Chicago. Terminated at 1 site in United States. Open to female participants aged 21 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University of Chicago · Not applicable, Interventional, and Basic science
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).
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.
84 studies on the registry are indexed under Hypokinesia; 10 are open to participants now.
This study's enrollment of 57 is close to the median of 60 across 65 interventional studies indexed under Hypokinesia.
Browse Hypokinesia studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Flibanserin * 8 weeks * 100mg once daily at bedtime
Drug: Flibanserin
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
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
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
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).
Time frame: 8 weeks
Eye Movement Tracking: Movements to First Saccades
Change from baseline eye movement tracking results at 8 weeks.
Time frame: 8 weeks
| Milestone | Flibanserin | Placebo |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
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).
No measurements were reported for this outcome.
Change from baseline eye movement tracking results at 8 weeks.
No measurements were reported for this outcome.
Collected over All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Flibanserin | — | — | — |
| Placebo | — | — | — |
No data was collected or analyzed
| Age, Categorical | Flibanserin | Placebo | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | Flibanserin | Placebo | Total |
|---|
| Sex: Female, Male | Flibanserin | Placebo | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race (NIH/OMB) | Flibanserin | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | — | — |
| Asian | — | — | — |
| Native Hawaiian or Other Pacific Islander | — | — | — |
| Black or African American | — | — | — |
| White | — | — | — |
| More than one race | — | — | — |
| Unknown or Not Reported | — | — | — |
| Region of Enrollment(participants) | Flibanserin | Placebo | Total |
|---|
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Plan to share: No
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