Effects of Flibanserin on the Pre- and Post-menopausal Female Brain
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ClinicalTrials.gov Identifier: NCT02770768 |
Recruitment Status :
Recruiting
First Posted : May 12, 2016
Last Update Posted : November 4, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoactive Sexual Desire Disorder | Drug: Flibanserin Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Flibanserin and Women With Hypoactive Sexual Desire Disorder: A Double-Blind, Randomized, Electrical Neuroimaging Study |
Study Start Date : | October 2016 |
Estimated Primary Completion Date : | June 1, 2020 |
Estimated Study Completion Date : | June 1, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Flibanserin
Drug: Flibanserin
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Drug: Flibanserin
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.
Other Name: Addyi |
Placebo Comparator: Placebo
Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)
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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.
Other Name: Matching placebo |
- EEG Results: Evoked Brain Potentials (measured brain response that is the direct result of a specific cognitive event) [ Time Frame: 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).
- Eye movement tracking: movements to first saccades [ Time Frame: 8 weeks ]Change from baseline eye movement tracking results at 8 weeks.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 74 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770768
Contact: Erika Kaske | 773-834-5264 | ekaske@yoda.bsd.uchicago.edu |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Erika Kaske 773-834-5264 ekaske@yoda.bsd.uchicago.edu | |
Contact: Stephanie Cacioppo, PhD 773-702-6983 scacioppo@yoda.bsd.uchicago.edu | |
Principal Investigator: Stephanie Cacioppo, PhD | |
Sub-Investigator: Jon E Grant, JD, MD, MPH | |
Sub-Investigator: Royce Lee, MD |
Principal Investigator: | Stephanie Cacioppo, PhD | University of Chicago | |
Principal Investigator: | Jon E Grant, MD, JD, MPH | University of Chicago |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT02770768 |
Other Study ID Numbers: |
IRB16-0087 |
First Posted: | May 12, 2016 Key Record Dates |
Last Update Posted: | November 4, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
HSDD (Hypoactive Sexual Desire Disorder) EEG (Electroencephalogram) |
Hypokinesia Sexual Dysfunctions, Psychological Dyskinesias |
Neurologic Manifestations Nervous System Diseases Mental Disorders |