Clinical trial NCT02770768
Conditions: Hypoactive Sexual Desire Disorder
Keywords: HSDD (Hypoactive Sexual Desire Disorder) EEG (Electroencephalogram)
Sponsor: University of Chicago
Start date: 2016-10-01; Completion date: 2021-12-21
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Drug: Flibanserin

* 8 weeks
* 100mg once daily at bedtime arm 2: Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)
Interventions: intervention 1: Flibanserin intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents:
Prot_SAP_000.pdf: 
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Effects of Flibanserin on the Pre- and Post-menopausal Female Brain 
IRB16-0087 
NCT02770768 
Protocol Version 3/20/2019  
 
 


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HSDD, EEG, and Flibanserin Study Detailed Protocol Narrative 
1. Background: 
Hypoactive sexual desire disorder (HSDD) is the most common sexual complaint in 
women. Over the past 8 years, Dr. Stephanie Cacioppo (née Ortigue) Ph.D. has 
developed and validated the Desire Intention task (DIT; e.g., Bolmont et al., 2014; 
Cacioppo et al., 2013; Ortigue & Bianchi-Demicheli, 2008), 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. This task has been IRB approved 
previously (IRB#12-2229). In a functional magnetic resonance imaging (fMRI) study Dr. 
Stephanie Cacioppo discovered that women with HSDD, compared to normal controls, 
show a hypoactivation of the neural network known to sustain sexual desire in healthy 
non-HSDD individuals (Bianchi-Demicheli et al., 2011; Cacioppo & Hatfield, 2013; 
Cacioppo et al., 2012), including dopamine-rich limbic regions associated with reward 
processing, and a hyperactivation of brain regions involved when people view 
themselves from a third-person perspective (“spectatoring”) rather than from a first 
person perspective when viewing sexually desirable stimuli (Bianchi-Demicheli et al., 
2011; Cacioppo and Cacioppo, 2013). ). A caveat with fMRI is that it does not inform us 
about the temporal dynamics between these brain areas. In 2008, Dr. Stephanie 
Cacioppo was also the first to identify the brain microstate underlying sexual desire in 
healthy non-HSDD subjects (Ortigue & Bianchi-Demicheli, 2008). The proposed study 
will be the first to address this question in patients with HSDD pre- and post-flibanserin.    
 
Flibanserin (Addyi) is a new medication approved by the FDA for the treatment of pre-
menopausal women with HSDD. We 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 
(as measures with self-report measures of sexual desire and eye-tracking movements).  
 
 


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2. Purpose: 
 
The research question of this double-blind randomized outpatient clinical trial is 
to determine the pre-post change in the Flibanserin group and investigate the extent to 
which Flibanserin normalizes brain activity in premenopausal and postmenopausal 
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).  
 
3. Aims: 
Aim 1: By targeting deficits in subjective desire in postmenopausal women with 
hypoactive sexual desire disorder, flibanserin may offer a unique mechanism to address 
HSDD. Because of the pharmacology of flibanserin and its effects on the brain circuitry 
of emotion and its positive and already accepted effects on premenopausal women with 
HSDD, we hypothesize that subjective feelings and neurobehavioral responses to 
sexually desirable stimuli are improved after an 8-week intake of flibanserin versus 
placebo. 
Aim 2: All women, independent of hormonal phase, should demonstrate similar 
responses. We hypothesize that similar changes should be observed in premenopausal 
and postmenopausal women after an 8-week intake of flibanserin versus placebo. 
 
4. Primary Outcome Measure: 
EEG Results: Evoked Brain Potentials (measured brain response that is the direct result 
of a specific cognitive event). We will be analyzing change from baseline EEG results at 
8 weeks (before and after the subject takes the flibanserin or placebo). We will average 
the electrical brain activity evoked by each type of stimuli to calculate the evoked brain 
potentials (any stereotyped electrophysical response to a stimulus). 
Evoked brain potentials in response to sexually desired stimuli compared to: 
1.  Non sexually desired stimuli  
2. Basic visual non-sexual stimuli (reversal checkerboard) will be our proposed 
endpoints, as they will allow us to measure electric brain signals specific to cognitive 


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mechanisms underlying sexual stimuli processing rather than any other non-cognitive 
processes or basic visual processes.  Amplitude of the signal, latency, and brain 
topography across 128 recorded vectors will be measured. 
Secondary Outcome Measures: 
-Eye movement tracking: movements to first saccades. We will be analyzing change 
from baseline eye movement tracking results at 8 weeks. 
-Female Sexual Function Index: change from baseline to final score at 8 weeks. 
-UCLA Loneliness Scale: change from baseline to final score at 8 weeks. 
-Life Satisfaction Scale: change from baseline to final score at 8 weeks. 
-Body Dysmorphic Disorder Questionnaire: change in answers from baseline to final 
visit at 8 weeks. 
-Hamilton Anxiety and Depression Scale: change from baseline to final score at 8 
weeks. 
-Rosenberg Self-Esteem Scale: change from baseline to final score at 8 weeks. 
-Hostility Measure: change from baseline to final score at 8 weeks. 
Female Sexual Distress Scale-Revised: change from baseline to final score at 8 weeks. 
IOS Scale with Partner: change in answers from baseline to final answers at 8 weeks. 
Body image measure: change in baseline to final score at 8 weeks. 
Sexual Desire Inventory: change in baseline to final score at 8 weeks. 
Marital Satisfaction Scale: change in baseline to final score at 8 weeks. 
 
5. Methodology: 
 
The proposed study aims to test 60 pre-menopausal heterosexual or bisexual 
women (i.e., women who are menstruating) and 60 postmenopausal heterosexual or 
bisexual women (women who are no longer menstruating for at least 6 months) with 
hypoactive sexual desire disorder (HSDD) and investigate how their brain activity (as 
measured by non-invasive surface electroencephalogram, EEG) responds to desirable 
stimuli (photographs of models in business suits) before and after the administration of 
an FDA approved drug, Addyi (ingredient Flibanserin, NDA# 022526) for sexual desire 
disorder. The goal of this experiment is to investigate how the subjects’ brain waves and 
their subjective desire for sexual activity change after an 8-week intake of Addyi 


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(Flibanserin; 100mg at bedtime)—an FDA approved drug for the treatment of 
hypoactive sexual desire disorder (HSDD) in premenopausal women (but not FDA 
approved in postmenopausal women) or after an 8-week intake of a placebo. The 
pharmacist will randomly assign once the subject to the treatment group (group with 
Flibanserin) or to the control group (group with placebo). Before and then again after the 
8-week regimen, the patient will be asked to fill-out a series of questionnaires (e.g., 
demographics, body image; sexual desire) and do a behavioral visual task on a 
computer while the patient’s brain activity (brain waves) and eye-movement will be 
recorded using a non-invasive high-density electroencephalogram (EEG) system and a 
non-invasive eye-tracking system, respectively. At mid-term (at 4 weeks), the patient will 
be also asked to fill-out the same series of questionnaires (e.g., demographics, body 
image; sexual desire) and do the same behavioral visual task on a computer while the 
patient’s brain activity (brain waves) and eye-movement will be recorded using a non-
invasive high-density electroencephalogram (EEG) system and a non-invasive eye-
tracking system, respectively. 
Subjects will be recruited via Flyers posted on Campus and/or in Obstetrics and 
Gynecology practices and/or via ads posted on Craigslist by research coordinator, 
Sarah Redden. From these ads, interested individuals will be asked to go on Survey 
Monkey (https://www.surveymonkey.com/r/HPENlabresearch) and complete a survey 
that will help us determine whether they meet our selection criteria or email Dr. 
Cacioppo at hpen@uchicago.edu or call the research team. Research coordinator will 
then contact individuals who may meet selection criteria. She and Dr. Grant and/or Dr. 
Lee will meet with them and give them the informed consent to read and go through it 
with the subjects. Upon receipt of a signed informed consent, participants will meet with 
Dr. Grant or Dr. Lee who will diagnose them with HSDD. If the subject does not have 
HSDD, she is not eligible to participate in the study. Subjects with a confirmed diagnosis 
of HSDD by Dr. Grant or Dr. Lee will then be randomly assigned by the UChicago 
Pharmacy/Investigational Drug Service to either Addyi (100 mg once daily at bedtime 
for 8 weeks, n = 60 subjects) or placebo (100 mg once daily at bedtime for 8 weeks, n = 
60 subjects). The research question of this double-blind randomized outpatient clinical 
trial is to determine the pre-post change in the Flibanserin group and investigate the 


6 
 
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 (as measured with self-report measures of sexual desire and/or eye-tracking 
movements).  
The study is registered on clinicaltrials.gov. 
 
6. Duration of Protocol: 
The total duration of the entire study on campus is 4.5 hours maximum. Visit 1’s 
duration: 2 hours. Upon receipt of the subject’s written consent, the subject will meet 
with Dr. Grant or Dr. Lee to have a diagnosis of HSDD confirmed, take a urine pregnancy 
test, and be asked to fill out questionnaires (duration 45 minutes maximum). Then, an 
IRB-approved member of the HPEN laboratory will walk the subject to the laboratory 
where the subject will be completing other questionnaires and performing the behavioral 
visual task while the subject’s brain activity and eye movements are recorded (1h15 
minutes maximum, including breaks and time to walk to the laboratory). At the end of Visit 
1, a member of the HPEN laboratory will walk the subject to the pharmacy where they will 
receive either Flibanserin or Placebo. The HPEN member will not know what the patient 
receives (placebo or Flibanserin). One week after visit 1, a member of the study staff will 
contact the subject via telephone to see if the subject has experienced any side effects 
or if the subject has any questions. If any side effects are reported, the study staff will 
immediately contact Dr. Grant or Dr. Lee to confirm that any appropriate follow up is 
provided. Phone call 2’s duration: 30 minutes. Two weeks after visit 1, the subject will 
be asked about any side effects she has experienced or is currently experiencing. The 
subject will also be asked to fill out some of the same questionnaires as visit 1 and answer 
questions about mood and sexual desire. Visit 2’s duration: 1 hour. The subject will go 
directly to the HPEN laboratory, where the subject will perform the behavioral visual task 
again while the subject’s brain activity and eye movements are recorded and fill out the 
same questionnaires the subject filled out during Visit 1. Visit 3’s duration: 1 hour. The 
subject will again go directly to the HPEN laboratory to perform the behavioral visual task 
while the subject’s brain activity and eye movements are recorded and fill out the same 
questionnaires as Visits 1 and 3.  


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7. Location of Study: 
 
Visit 1 part A  and visit 2 will take place in the Department of Psychiatry and 
Behavioral Neuroscience, 5841 S. Maryland Avenue, Chicago, IL, 60637), and visit 1 
part B (behavioral task, self-report questionnaires, EEG recordings, and eye-movement 
recordings), visit 2, and visit 3 will take place in the High-Performance Electrical 
Neuroimaging Laboratory. 940 E. 57th Street, 4th Floor, Chicago, IL 60637. 
 
8. Special Precautions:  
Precautions related to the contradictions of Addyi (Flibanserin) will be followed. 
This will occur in the survey monkey pre-screening survey and again in the consent 
form.  
9. Experimental Controls: 
 
We will recruit 60 pre-menopausal women and 60 postmenopausal women who 
have HSDD, as determined by one of the MDs on the research team (using the DSM 5 
criteria), during Visit 1. Then, the pharmacist will randomly assign the subjects to the 
treatment group (group with Flibanserin) or to the control group (group with placebo).  
 
10. Type and Number of Experimental Subjects: 
 
We expect to collect data from a total of 120 subjects between the age of 21 and 
74 years. We will be testing premenopausal and postmenopausal women with 
hypoactive sexual desire disorder. Flibanserin is FDA approved for premenopausal but 
not postmenopausal women with HSDD. Women who are pregnant (or think they are 
pregnant), or who are nursing (or breastfeeding), or women who report not being able to 
stop drinking alcohol during the duration of the study will NOT be tested.  
 
Power: Using G* power calculation software (Version 3.1.9.2) for a within-between 
interaction in repeated measures ANOVA, a total sample size of 120 will yield 95% 
power to detect a significance, with alpha = .05 and an effect size of 0.14. 
 
 


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11. Statistical Analyses: 
 
EEG data will be analyzed using an established Matlab toolbox, CENA (The 
Chicago Electrical Neuroimaging Analytics). Standard statistical analyses will be 
performed using SPSS. Compared to fMRI, which has a very low temporal resolution, 
high-density EEG/ERP has a very high temporal resolution (Ortigue & Bianchi-
Demicheli, 2008). When combined with brain source localization algorithms, high-
density EEG-ERP is called electrical neuroimaging. Electrical neuroimaging can identify 
dynamical patterns of communication between brain regions that contrast analyses, 
such as fMRI, may not detect. This proposal takes advantage of electrical neuroimaging 
and a new suite of tools (i.e., the Chicago Electrical Neuroimaging Analytics, CENA), 
that Dr. Stephanie Cacioppo developed and validated recently for segmenting high-
density electrical brain activity (Cacioppo et al., 2014, 2015). Compared to the standard 
waveform analysis of event-related potentials (ERP) components that provide local 
information about amplitude and latency of the brain electric signal collected from one 
electrode in response to a stimulus, CENA provides general information about the 
stable momentary configuration of the global scalp electric potential over a high-density 
multi-channel electrode array. This approach provides information about the temporal 
sequence of discrete information processing operations evoked by the presentation of a 
stimulus within the context of a particular experimental task. That temporal sequence of 
information processing includes a series of stable brain microstates, each of which is 
characterized by specific cognitive computations and a relatively stable spatial 
distribution of brain activity. Combined with brain source localization algorithms, this 
method can then provide a video-clip of the potential brain sources that sustain every 
electrical brain state recorded from the surface of the scalp –without having to perform 
an fMRI scan (see attached example). The brain microstate approach complements the 
traditional approach of ERP peaks and troughs at specific electrode positions, but with 
more comprehensive analyses of time-varying activity across the entire scalp (Cacioppo 
et al., 2014, 2015).   
 


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Subjects who do not adhere to the recommended dosing regimen will not be 
discontinued from the study. Rather, data from these subjects should be included in an 
intent-to-treat analysis. 
 
Statistical Hypotheses: 
a. 
The research questions of this double-blind randomized study are: (a) to 
determine the pre-post change in the Flibanserin group vs. Placebo group in women 
with hypoactive sexual desire disorder (HSDD), (b) to compare the effect is Flibanserin 
(vs. placebo) on behavioral and brain changes between pre-menopausal women and 
postmenopausal women, (c) to investigate the extent to which post-Flibanserin’s 
regional brain activations (compared to pre-Flibanserin’s regional brain activations) are 
associated with changes in symptoms and behavior (as measured with self-report 
measures of sexual desire and/or eye-tracking movements), and (d) to investigate the 
extent to which Flibanserin normalizes brain activity in women with HSDD compared to 
matched healthy controls. The statistical hypotheses include the following: 
i. 
Demographics: Statistical analyses for demographic and self-report measures 
will be computed using SPSS software. Prior to inferential analyses, descriptive 
statistics, including distributions, means, standard deviations, skewness, and kurtosis 
will be generated. Data will also be examined for the pattern and mechanism of missing 
data. Continuous data will be tested for normality and homogeneity of variance. 
Potential differences between the treatment and placebo groups in terms of 
demographic and behavioral measures will be explored using multivariate analysis of 
variance (MANOVA) or appropriate non-parametric tests as appropriate. Similar 
analyses will be performed to detect potential differences between the pre-menopausal 
subjects and the post-menopausal subjects. The overall significance level for these 
analyses will be at 5%, and effect sizes and confidence intervals will also be performed 
to test hypotheses about correlations. 
ii. 
Behavioral data: Statistical analyses will be computed using SPSS software. 
Reaction times and performance data (ratings) will be screened. Prior to inferential 
analyses, descriptive statistics, including distributions, means, standard deviations, 
skewness, and kurtosis will be generated. Data will also be examined for the pattern 


10 
 
and mechanism of missing data. A 2 (Treatment Type: Addyi or Placebo) x 2 (Group 
Type: pre- or post-menopausal) X 2 (type of stimuli: desired, nondesired) x 3 time (Visit 
1, Visit 2, Visit 3) repeated-measures ANOVA will be performed on the reaction times 
and ratings to assess for main effects and interaction effects. P values, confidence 
interval, and effect sizes will be reported. 
iii. 
Eye-tracking Data: A similar ANOVA will be performed for the following 
dependent variables: onset to first fixation and duration of fixation. As in our 2014’s 
paper (Bolmont, Cacioppo, & Cacioppo), we will also analyzed include the subjects’ 
visual area of interest (face vs. body) as a within-subject factors in our ANOVA. 
iiii. 
 Electrophysiological Data: EEG data will be analyzed using an established 
Matlab toolbox, CENA (The Chicago Electrical Neuroimaging Analytics). Standard 
statistical analyses will be performed using SPSS. Compared to fMRI, which has a very 
low temporal resolution, high-density EEG/ERP has a very high temporal resolution 
(Ortigue & Bianchi-Demicheli, 2008). When combined with brain source localization 
algorithms, high-density EEG-ERP is called electrical neuroimaging. Electrical 
neuroimaging can identify dynamical patterns of communication between brain regions 
that contrast analyses, such as fMRI, may not detect. This proposal takes advantage of 
electrical neuroimaging and a new suite of tools (i.e., the Chicago Electrical 
Neuroimaging Analytics, CENA), that Dr. Stephanie Cacioppo developed and validated 
recently for segmenting high-density electrical brain activity (Cacioppo et al., 2014, 
2015). Compared to the standard waveform analysis of event-related potentials (ERP) 
components that provide local information about amplitude and latency of the brain 
electric signal collected from one electrode in response to a stimulus, CENA provides 
general information about the stable momentary configuration of the global scalp 
electric potential over a high-density multi-channel electrode array. This approach 
provides information about the temporal sequence of discrete information processing 
operations evoked by the presentation of a stimulus within the context of a particular 
experimental task. That temporal sequence of information processing includes a series 
of stable brain microstates, each of which is characterized by specific cognitive 
computations and a relatively stable spatial distribution of brain activity. Combined with 
brain source localization algorithms, this method can then provide a video-clip of the 


11 
 
potential brain sources that sustain every electrical brain state recorded from the 
surface of the scalp –without having to perform an fMRI scan (see attached example). 
The brain microstate approach complements the traditional approach of ERP peaks and 
troughs at specific electrode positions, but with more comprehensive analyses of time-
varying activity across the entire scalp (Cacioppo et al., 2014, 2015). 
 
A significant and clinically meaningful change from baseline for each subject pre- and 
post-treatment with flibanserin is as follows: 
 
Median effective doses of flibanserin on increase in SD level will demonstrate at 
least a medium effect size (e.g., Coden’s d > 0.48) relative to placebo (PBO); and at 
least a medium effect size (Coden’s d > 0.48) between flibanserin and PBO conditions 
in SD levels; and relationship between change in SD self-report levels and change in 
behavioral responses (reaction times) during SD paradigm in flibanserin (vs PBO) is of 
at least a medium effect size (r > 0.48); or relationship between change in flibanserin 
and change in electrophysiological responses during SD paradigms in flibanserin (vs. 
PBO) is of at least a medium effect size (r > 0.48); Relationship between change in 
Flibanserin and change in eye movement responses during SD paradigms in 
Flibanserin(vs. PBO) is of at least a medium effect size (r > 0.48). There will be no 
adverse events of more than mild severity which are rated as possibly, probably, or 
definitely related to acute, oral administration of flibanserin to a greater extent than PBO 
in HSDD participants. 
 
12. Potential Risks and Benefits: 
 
The study will offer no direct benefits (besides monetary benefits and potential 
improvement of sexual desire) to participants. The questionnaires, tracking eye-
movement, and EEG behavioral task also present minimal risks, which may include 
boredom and fatigue from looking at pictures for a few minutes during EEG collection 
and anxiety or discomfort or distress related to responding to questionnaires.  
Addyi risks: Addyi (flibanserin) is a multifunctional serotonin agonist and antagonist 
(MSAA) indicated for the treatment of premenopausal women with acquired, 
generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual 


12 
 
desire that causes marked distress or interpersonal difficulty and is NOT due to: a co-
existing medical or psychiatric condition, problems within the relationship, or the effects 
of a medication or other drug substance. The recommended dosage of Addyi is 100 mg 
taken once daily at bedtime.  
 
CONTRAINDICATIONS: Alcohol; Moderate or strong cytochrome P450 3A4 inhibitors; 
Hepatic impairment.  
 
IF THE SUBJECTS ARE A NURSING MOTHER, THEIR PARTICIPATION IS NOT 
RECOMMENDED.  
 
IF THE SUBJECTS ARE PREGNANT, YOUR PARTICIPATION CANNOT BE 
ACCEPTED.  
 
DRUG INTERACTIONS: Oral contraceptives increase Flibanserin exposures and 
incidence of adverse effects.  
 
FDA-approved Flibanserin has known sides effects we want you to be aware of, such 
as syncope and Central Nervous System (CNS) depression. 
 
Other common side effects of Addyi (Flibanserin) include: dizziness, sleepiness, 
nausea, fatigue, insomnia, and dry mouth. Other side effects of Addyi include anxiety, 
constipation, abdominal pain, menstrual spotting, rash, sedation, and spinning 
sensation (vertigo). 
 
Addyi may interact with alcohol, CNS depressants (such as diphenhydramine, 
opioids, hypnotics, benzodiazepines), antifungals, antiviral drugs, grapefruit juice, oral 
contraceptives, cimetidine, fluoxetine, ginkgo, ranitidine, proton pump inhibitors, 
selective serotonin reuptake inhibitors (SSRIs), some antibiotics, nefazodone, , 
ketoconazole, itraconazole, posaconazole, clarithromycin, ritonavir, saquinavir, 
nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan, amprenavir, 


13 
 
atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, 
verapamil, paroxetine, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, 
rifapetine, St. Johns Wort, digoxin, sirolimus, and some medicines used to treat high 
blood pressure, chest pain (angina), or other heart problems.  
 
Drug interactions can be found in all tables including CYP3A4 inhibitors and CYP2C19 
on: 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugI
nteractionsLabeling/ucm093664.htm 
Note: The use of moderate or strong CYP3A4 inhibitors is contraindicated in patients 
taking flibanserin, and flibanserin may interact with other medications (weak CYP3A4 
inhibitors, strong CYP219 inhibitors, CYP3A4 inducers, and digoxin. 
 
Addyi is only available through the Addyi risk evaluation and mitigation strategy 
(REMS) Program because of the increased risk of severe low blood pressure and 
fainting (loss of consciousness) with alcohol use. By agreeing to participate in 
the present study and by signing the present consent form, the subject also 
agrees NOT to drink alcohol or beverages including alcohol while taking Addyi 
(Flibanserin), that is for a period of 8 weeks.  
If the subject feels that they won’t be able to follow a non-alcoholic diet for 8 weeks, 
they will be asked to tell the research team. We will compensate them for their time 
spent with us. 


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15 
 
 
 


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Accidental Injury 
In five trials of premenopausal women with HSDD, accidental injury was reported in 
42/1543 (2.7%) ADDYI-treated patients and 47/1905 (2.5%) placebo-treated patients. 
Among these 89 patients who experienced injuries,9/42 (21%) ADDYI-treated patients 
and 3/47 (6%) placebo-treated patients reported adverse reactions consistent with CNS 
depression (e.g.,somnolence, fatigue, or sedation) within the preceding 24 hours. 
 
Source: http://www.rxlist.com/addyi-side-effects-drug-center.htm 
 
 
 


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13. Monitoring of Safety: 
 
A researcher will be present with participants during the duration of the 
experiment. While participants are in a separate room sheltered from electrical 
interference for EEG recording, researchers will monitor participants’ well-being via 
cameras and microphones within this room. Participants will have the ability to 
communicate with researchers through these microphones and may opt out of 
participation at any time. Participants will also be provided with the IRB’s contact 
information on the consent form, and we will contact IRB should any adverse effects 
occur. 
Participants will be advised not to drive, operate machinery, or do things that require 
clear thinking until at least 6 hours after taking flibanserin and until they know how 
flibanserin affects them. This has been addressed in the informed consent and will be 
discussed with participants. 
Regarding Addyi’s side effects:  Subjects will be directed to call a member of the study 
team if they believe they are experiencing any side effects.  
Vital signs (blood pressure, pulse, respiratory rate, temperature, height, weight) will be 
obtained at every visit. Orthostatic vital signs will be used in terms of blood pressure 
and pulse. 
 
No baseline laboratory testing will be done. 
 
14. Payment:  
Participants will receive a parking voucher or $ 5 for public transportation at the 
end of every visit. At the end of each visit, participants will also receive $20 monetary 
compensation for their participation in the study. At the end of visit 3, participants will 
receive also receive $50 monetary compensation for completing the entire study.  
 
15. Informed Consent: 
 
Participants will be provided with the consent form attached in this IRB 
application. Participants must acknowledge understanding of procedures, risks, and 
benefits by signing this consent form before the study can proceed. 
 


18 
 
16. Confidentiality: 
 
De-identified data will be stored in locked drawers or cabinets or on password-
protected computers within the HPEN laboratory or on password protected University of 
Chicago server, such as UChicago Box. Data may be used in publications, but no 
personally identifiable information will be disseminated outside of researchers included 
in this protocol. 
17. References to Justify Study: 
Bianchi-Demicheli, F., Cojan, Y., Waber, L., Recordon, N., Vuilleumier, P., Ortigue, S. 
(2011). Neural bases of hypoactive sexual desire disorder in women: an event-related 
fMRI study. Journal of Sexual Medicine, 8, 2546-2559.   
 
Bolmont, M., Cacioppo, J.T., & Cacioppo, S. (2014). Love is in the gaze: An eye-
tracking study of love and sexual desire. Psychological Science. July 16. pii: 
0956797614539706.  
 
Cacioppo, S., Bianchi-Demicheli, F., Frum, C., Pfaus, J., Lewis, J.W. (2012). 
The common neural bases between sexual desire and love: a multilevel kernel 
density fMRI analysis. Journal of Sexual Medicine, 9, 1048-1054. doi: 10.1111/j.1743-
6109.2012.02651.x  
 
Cacioppo, S., & Cacioppo, J.T. (2013). Lust for life. Scientific American Mind, 24, 56-63.  
 
Cacioppo, S., & Cacioppo, J. T. (2015). Dynamic spatiotemporal brain analyses using 
high-performance electrical neuroimaging, Part II: A Step-by-Step Tutorial. Journal of 
Neuroscience Methods, 256: 184-197. pii: S0165-0270(15)00337-4. Doi: 
10.1016/j.jneumeth.2015.09.004.  
 
Cacioppo S., Couto B., Bolmont M., Sedeno L., Frum C., Lewis, J. W., Manes 
F., Ibanez  A., Cacioppo, J. T. (2013) Selective decision-making deficit in love following 
damage to the anterior insula. Current Trends in Neurology, 7, 15-19.  
 


19 
 
Cacioppo, S. & Hatfield, E. (2013). From desire to love: New advances from social 
neuroscience.  In L. Bormans (Eds). “The World Book of Love" (pp. 116-119). Tielt, 
Belgium: Lannoo Publishers.  
 
Cacioppo, S., Weiss, R. M. Runesha, H. B., & Cacioppo, J. T. (2014). Dynamic 
Spatiotemporal Brain Analyses using High Performance Electrical NeuroImaging: 
Theoretical Framework and Validation. Journal of Neuroscience Methods, 238, 11-34. 
doi: 10.1016/j.jneumeth.2014.09.009.  
 
Ortigue, S. & Bianchi-Demicheli, F. (2008). The chronoarchitecture of human sexual 
desire: a high-density electrical mapping study. NeuroImage 43, 337-345.   
 
18. Recruiting Methods:  
 
Subjects will be recruited via Flyers posted on Campus or Obstetrics and 
Gynecology practices or via ads posted on Craigslist. 
 
19. Primary Physician Notification:  
Dr. Jon Grant, M.D.  
 
20. Anticipated Coordination between Inter-Departmental Faculty: 
 
Stephanie Cacioppo, Ph.D., Jon Grant, M.D., and Royce Lee, M.D. are all 
members of the Department of Psychiatry and Behavioral Neuroscience. These 
researchers will coordinate extensively on this project. 
 
21. Pregnancy Test:  Conducted at screening visit. 
22. Acceptable forms of birth control: oral contraceptives (e.g., combined pill or 
progestin only pill), intrauterine device, shot/injection, partner uses a male condom, 
vaginal ring, birth control patch, and abstinence. 
 
Any pregnancy conceived during this study will be followed and its 
outcome (both maternal and neonatal) will be reported. 
 


20 
 
23. Inclusion/Exclusion Criteria: 
Inclusion: 
- 
Female 
- 
Between 21 and 74 years old 
- 
Menstruating for pre-menopausal and not mensutrating for at least 6 months for the 
post-menopausal women. The FDA defines postmenopausal as: 12 months of 
spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH 
levels >40mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without 
hysterectomy (U.S. Department of Health and Human Services, 2003). 
Premenopausal is defined as the period in a woman’s life preceding menopause. 
- 
DSM-5 diagnosis of hypoactive sexual desire disorder (HSDD) (also called disorder 
in sexual thoughts or interests) 
Exclusion: 
- 
Male 
- 
< 21 years-old or > 74 years-old 
- 
Hairstyles that induce artifacts to the EEG recording (i.e. braids, weave, extensions)   
- 
Currently taking psychotropic medication 
- 
Currently pregnant or lactating 
- 
Women who report not being able to stop drinking alcohol during the duration of the 
study 
- 
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 
- 
Uncorrected vision 
- 
Hepatic impairment 
 
 


21 
 
 
24. Study Drug Compliance: 
 
In order to assess study drug compliance, we will ask subjects to bring back any 
unused medication at their next visit. Any missed doses will be accounted for by 
counting the number of pills the subject returns. 
25. Study Drug Dispensation: 
 
During the first visit, after Dr. Jon Grant or Dr. Royce Lee meet with the subject 
and determine if the subject is eligible to participate in the study, one of them will send a 
prescription to the investigational drug services (IDS) pharmacy at the University of 
Chicago Medical Center. The prescription is based on a randomization chart, so the 
physicians will order the drug by placing a coded patient number on the prescription 
sheet. When sent to the IDS pharmacy, they will know if that specific ID number is 
randomized to the flibanserin or the placebo, thus keeping it blinded to the physicians. 
Shortly after the study drug is ordered, a member of the study staff will pick it up from 
the IDS pharmacy and deliver it to the EEG lab where the subject will be doing the EEG 
procedures. After the subject is finished with all visit procedures, she will be given the 
study drug and instructions on how to take it. 
 
All tablets will be dispensed at one time during the first visit. The total number of 
tablets each subject will receive is 56 tablets (8 weeks x 1 tablet/day). 
26. Institutional Review Board (IRB): 
 
The supervisory role of the IRB includes reviewing, approving, and monitoring all 
aspects of this research. All changes that are made to the study are always approved 
by the IRB before being implemented. The University of Chicago IRB follows the ethical 
principles consistent with the Declaration of Helsinki of the World Health Organization 
and the Belmont Report. It follows the policies of the FDA, the protection of human 
subjects, and others. Please follow link to read more: 
http://bsdirb.bsd.uchicago.edu/policies-procedures/index.html 
27. Prohibited Medications 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugI
nteractionsLabeling/ucm093664.htm (refer to section 12 for more information) 
 
 
The following medications are not to be taken by eligible subjects: 


22 
 
atazanavir; azamulin; buspirone; Clarithromycin; darunavir; dextromethorphan N-
demethylation; digoxin; eletriptan; erythromycin N-demethylation; felodipine; indinavir; 
itraconazole; ketoconazole; lopinavir; lovastatin; midazolam 1-hydroxylation; 
midazolam; nefazodone; nelfinavir; nifedipine oxidation; Nootkatone; rifampin; ritonavir;  
saquinavir; sildenafil; simvastatin; telithromycin; terfenadine C-hydroxylation; 
testosterone 6 b –hydroxylation; ticlopidine; tipranavir; triazolam 4-hydroxylation 
triazolam; troleandomycin; verapamil. 
 
28. Adverse Events: 
 
Dr. Stephanie Cacioppo, Dr. Jon Grant, and Dr. Royce Lee will be responsible for 
the detection, documentation, classification, reporting, and follow-up of adverse events, 
including events meeting the definition of a serious adverse event (SAE). An adverse 
event (AE) us any undesirable experience associated with the use of a medical product 
in a patient. For the regulatory definitions of SAEs, refer to 
http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm. 
All AEs will be recorded regardless of causality or severity. At the minimum, information 
collected concerning AEs should include the following: onset date, resolution date, 
severity (i.e., mild, moderate, or severe), relationship to study drug, intervention (if 
needed), seriousness of the event, and outcome. 
 
 

ICF_001.pdf: 
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The UNIVERSITY OF CHICAGO
The Division of the Biological Sciences  The University of Chicago Medical Center
CONSENT/AUTHORIZATION BY SUBJECT FOR PARTICIPATION IN A RESEARCH 
PROTOCOL
Protocol Number: 16-0087
Name of Subject:  
STUDY TITLE:  Spatiotemporal Dynamics of Flibanserin in the Female Brain
Doctors Directing Research: Dr. Stephanie Cacioppo, Dr. Jon Grant, & Dr. Royce Lee
Address: University of Chicago Medical Center
   Department of Psychiatry
   5841 South Maryland Avenue, MC 3077
Telephone Number: 773-702-6983
You are being asked to participate in a research study. A member of the research team will 
explain what is involved in this study and how it will affect you. This consent form describes the study 
procedures, the risks and benefits of participation, as well as how your confidentiality will be 
maintained. Please take your time to ask questions and feel comfortable making a decision whether to 
participate or not. This process is called informed consent.  If you decide to participate in this study, you 
will be asked to sign this form. 
WHY IS THIS STUDY BEING DONE?
The purpose of this study is to investigate how your brain waves and your subjective desire or 
sexual activity change after an 8-week intake of Addyi (Flibanserin; 100mg at bedtime)- an FDA 
approved drug for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal 
women or after an 8-week intake of a placebo (sugar pill). Flibanserin is not FDA approved for 
hypoactive sexual desire disorder in post-menopausal women. 
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
About 120 people with HSDD will take part in this study at the University of Chicago.
WHAT IS INVOLVED IN THE STUDY?
The study lasts 8 weeks and includes three office visits. During the first visit, you will be 
randomly assigned to the treatment group (group who takes the Flibanserin) or the control group 
(group who takes the placebo). Neither the study personnel nor you will know whether you are 
taking the study drug or the placebo. This is what is meant by “blinding.” Whether you receive 
the study drug or the placebo is based on a 50/50 chance, like flipping a coin. In all, 60 subjects 
will receive the Flibanserin and 60 subjects will receive the placebo.
Before, during, and after the 8-week regimen, you will be asked to fill out a series of 
questionnaires (e.g., demographics, questions about body image and sexual desire) and do a 
behavioral visual task on a computer while your brain activity (brain waves) are recorded using a 
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non-invasive high-density electroencephalogram (EEG) system.
During your first visit (Visit 1), the following will occur:

The study will be discussed with you and you will be asked to sign this consent form.

You will be asked to take a urine pregnancy test to ensure that you are not pregnant at the 
time of the study. The pregnancy test must be negative for you to participate in the study.

A review of your medical history and your medications will be completed.

Your vital signs will be taken. This includes height, weight, blood pressure, pulse, 
respiratory rate, and temperature. As part of taking your blood pressure and pulse, you 
will be asked to first lie down for 5 minutes, and then your blood pressure and pulse will 
be taken the first time. You will then be asked to stand for one minute, after which we 
will take your blood pressure and pulse again. After standing for 2 more minutes, we will 
measure your blood pressure and pulse one more time.

A review of your family history, a review of family medical issues and psychiatric issues 
will be discussed with you.

You will complete several questionnaires, including questions about your body image 
and your sexual desire.

You will do a behavioral visual task on a computer while your brain activity (brain 
waves) is (are) recorded using a non-invasive, high-density electroencephalogram (EEG) 
system.

Your eye-movements will also be recorded using a non-invasive eye-tracking system.

Study drug (Flibanserin or placebo) will be given to you.  You will take the study drug or 
placebo, whichever you are given, each night at bedtime. Do not drive, operate 
machinery, or do other things that require clear thinking until at least 6 hours after 
taking flibanserin and until you know how flibanserin affects you. If you have any 
questions about this, please ask a member of the study staff.

You will be given a parking voucher or $5 for public transportation and a $20 monetary 
compensation for participating in the study thus far.

Estimated Duration of Visit 1: 2 hours
One week after your first visit, we will call you on the phone to see how you are doing and ask if 
you have been experiencing any side effects.

Estimated Duration of Phone Call 1: 15 minutes
Two weeks after your first visit, you will call you again and ask you a few questions. These 
questions will be about your mood, your weight, your sexual desire, and any side effects you 
may be experiencing.

You will be asked to complete some of the questionnaires that you completed at your first 
visit.

You will continue to take the study drug or placebo each night at bedtime.

Estimated Duration of Phone Call 2: 30 minutes
Four weeks after your first visit, you will return for your second visit (Visit 2), in which the 
following will occur:
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
You will complete the questionnaires again.

Your vital signs will be taken again.

You will do the behavioral visual task on a computer while your brain activity (brain 
waves) is (are) recorded using a non-invasive, high-intensity EEG system.

Your eye-movements will also be recorded using a non-invasive eye-tracking system.

You will continue to take the study drug or placebo each night at bedtime.

You will be given a parking voucher or $5 for public transportation and a $20 monetary 
compensation for participating in the study thus far.

Estimated Duration of Visit 2: 1 hour
Eight weeks after your first visit, you will return for your third and final visit (Visit 3), in which 
the following will occur:

You will complete the questionnaires again.

Your vital signs will be taken again.

You will do the behavioral visual task on a computer while your brain activity (brain 
waves) is (are) recorded using a non-invasive, high-intensity EEG system.

Your eye-movements will also be recorded using a non-invasive eye-tracking system.

You will stop taking the study drug or placebo after this visit.

You will be given a parking voucher or $5 for public transportation and a $20 monetary 
compensation for participating in the study thus far.

In addition, you will receive a $50 for your completion of the entire study.

Estimated Duration of Visit 3: 1 hour
Behavioral visual task: You will be shown some desirable or neutral images and/or words on a 
computer. No pictures involving nudity will be presented. However, some of these images may 
be stressful, but should not be overwhelming. If you feel uncomfortable at any time, please alert 
the study staff immediately.
During the behavioral visual task, an EEG cap will be placed gently on the surface of your 
scalp. The cap contains 128 sponge-electrodes, which rest on the scalp and record brain 
electrical activity by calculating potential differences between each electrode and a reference 
electrode. Electro-conductive solution including water, potassium chloride and shampoo will 
be applied to the recording electrodes. No paste or gel will be applied between the electrodes 
and your scalp. This is a great advantage of this non-invasive EEG method, which allows 
setting up the cap in under 15 minutes of each testing session. During recording of your brain 
waves, you sit comfortably in a chair, while you will be required to fixate on a cross in the 
middle of the screen and hit buttons on a keyboard when presented with perceptual target 
stimuli. Standard EEG recording equipment protects the volunteer from any hazard of 
electrical shock using isolated grounding procedures. 
An eye-tracking system will also be in the room to record your eye-movements during the task. 
Both EEG and eye-tracking recordings are non-invasive approaches, which means that EEG and 
eye-tracking recordings can be performed without harm. 
During this study, Dr. Stephanie Cacioppo and her research team will collect information about 
you for the purposes of this research. This information includes name, date of birth, demographic 
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information, phone numbers, e-mail addresses, and the results of your study-related tests. Your 
behavioral data and EEG scan will be performed with a code number in the data field where a 
name would ordinarily go. Data from this study may be used in research publications or 
presentations or a registry shared between University of Chicago investigators. Your name and 
other identifying information will NOT be part of this data set. 
HOW LONG WILL I BE IN THE STUDY?
We think you will be in the study for 8 weeks where you will take the study drug or placebo each 
day. There is no long-term follow-up after you stop the study.
Dr.  Cacioppo may decide to take you off of the study without your consent if:

You are unable to meet the requirements of the study;

You drink alcohol during the 8 weeks;

Your medical condition changes;

The study drug is no longer available;

New information becomes available that indicates that participation in this study is not in 
your best interest; or

If the study is stopped.
WHAT ARE THE RISKS OF THE STUDY?
Addyi (Flibanserin) has a black box warning: the use of the study drug and alcohol increases the 
risk of hypotension (low blood pressure) and syncope (fainting). A black box warning means that the 
Food and Drug Administration (FDA) labels alcohol as having serious risks if combined with 
Flibanserin.
Addyi (Flibanserin) may interact with alcohol. By agreeing to participate in the present 
study and by signing this consent form, you also agree NOT to drink alcohol or beverages 
including alcohol while taking Addyi (Flibanserin) for a period of 8 weeks.
The most serious side effects observed in people taking Flibanserin are hypotension (low blood 
pressure) and central nervous system (CNS) depression. CNS depression refers to physical symptoms 
such as decreased rate of breathing, decreased heart rate, or loss of consciousness because of inhibited 
brain activity. If you experience any of these side effects, please notify the study doctor immediately. 
Appendicitis is also a risk associated with the study drug.
The most common side effects observed in people taking the study drug Addyi (Flibanserin) 
include:

Dizziness

Sleepiness

Nausea

Fatigue

Insomnia

Dry mouth
Other side effects include: anxiety, constipation, abdominal pain, menstrual spotting, rash, 
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sedation, fainting (syncope), spinning sensation (vertigo), and distressing dreams.
Oral contraceptives increase the likelihood of side effects occurring.
Flibanserin may interact with certain medications including central nervous system (CNS) 
depressants (such as diphenhydramine, opioids, hypnotics, benzodiazepines), antifungals 
(ketoconazole, itraconazole, posaconazole, fluconazole), antiviral drugs (telaprevir), 
antiretroviral drugs (ritonavir, saquinavir, nelfinavir, indinavir, amprenavir, atazanavir, 
fosamprenavir), antibiotics (clarithromycin, telithromycin, ciprofloxacin, erythromycin, 
rifabutin, rifampin, rifapetine), antihistamines (cimetidine, ranitidine), antidepressants and 
selective serotonin reuptake inhibitors (SSRIs) (nefazodone, fluoxetine, paroxetine), plants and 
plant-based medications (ginko, grapefruit juice, St. John’s wort, digoxin), protein pump 
inhibitors, protease inhibitors (boceprevir), barbiturates (phenobarbital), selective 
immunosupressants (sirolimus), seizure medication (carbamazepine, phenytoin), hyponatremia 
medication (conivaptan), hypertension medication (diltiazem, verapamil), and some medications 
used to treat high blood pressure, chest pain (angina), or other heart problems. Please tell us all 
medications and supplements you use. Please also inform the study doctor in the event that you 
begin taking any new antibiotics.
If you are pregnant or plan to become pregnant, you must let us know immediately as you are not 
eligible to participate in this study. It is unknown if Flibanserin will harm a fetus. Because of the 
potential for serious adverse reactions including sedation in a breastfed infant, breastfeeding is 
not recommended during treatment with Flibanserin.
You may be diagnosed with hypoactive sexual desire disorder. This may cause you feelings of 
distress. If you would like any treatment resources when the study is completed, we can provide 
you with that information.
  
There may be other risks that could arise which are not reasonably foreseeable. If new 
information becomes available which could influence your willingness to continue, this new 
information will be discussed with you.
The study team will also ask you questions about your mood and behaviors. These questions may 
make you feel uncomfortable. If at any time you would like to stop the interview, please let a 
member of the study staff know. 
Again, do not drive, operate machinery, or do other things that require clear thinking until 
at least 6 hours after taking flibanserin and until you know how flibanserin affects you. If 
you have any questions about this, please ask a member of the study staff.
ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY?
If you agree to take part in this study, there may or may not be direct medical benefit to you. We 
hope the information learned from this study will benefit other individuals with hypoactive 
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sexual desire disorder in the future.
WHAT OTHER OPTIONS ARE THERE?
Instead of being in this study, you have these options:
Addyi (Flibanserin) is FDA approved for the treatment of hypoactive sexual desire disorder in 
premenopausal women. An alternative option may be choosing to take Flibanserin without 
participating in the study for premenopausal women. Psychotherapy is an alternative option for 
both premenopausal and postmenopausal women with hypoactive sexual desire disorder. The 
decision whether or not you wish to participate in this study will not affect your care at the 
University of Chicago Medical Center.
WHAT ARE THE COSTS? 
Clinical services provided during a clinical trial are either research-related or related to usual 
medical care. Research-related services are done to complete the research and the costs are not 
the responsibility of you or your insurance. 
The costs that are considered research-related for this study may include any additional 
laboratory tests, physician visits, imaging, procedures or other clinical services that are dictated 
by the research protocol and only required because you are part of this study.  
Usual medical care costs include any and all services that are considered medically necessary for 
your disease and would be done even if you were not part of this research study. This may 
include laboratory tests, physician visits, imaging, procedures, and other clinical services that 
your physician orders for your routine care.  The cost of this usual, ongoing medical care will be 
the responsibility of you or your insurance, and may include deductibles and co-payments. 
Similarly, this care will be subject to all the same requirements and restrictions of your 
insurance. 
If you have questions about whether specific clinical services are research related or usual 
medical care, please speak to your physician or research contact person.
If you suffer an unanticipated injury as a direct result of this research and require emergency 
medical treatment, the University of Chicago Medical Center will provide such treatment at the 
University of Chicago Medical Center at no cost to you.  You must notify Dr. Cacioppo or Dr. 
Grant as promptly as possible after your injury in order to receive this care.  An injury is 
“unanticipated” if it is not one of the known effects of a study drug, medical device or procedure, 
and is not the result of your disease or condition. The costs of any non-emergency care for such 
an injury will be billed to you or your insurance in the ordinary manner.  If you think that you 
have suffered a research related injury, you must let Dr. Cacioppo or Dr. Grant know right away.
WILL I BE PAID FOR MY PARTICIPATION?
You will receive up to $125 monetary compensation for your participation in the study. You will 
receive the first payment of $20 at the end of visit 1, another $20 at the end of visit 2, another 
$20 at the end of visit 3. If you complete the entire study, you will also receive a $50 bonus at 
the end of visit 3. Also, after each visit, you will receive a parking voucher or $5 for public 
transportation. 
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WHAT ABOUT CONFIDENTIALITY?
Study records that identify you will be kept confidential. All of the data will be kept in a secure 
computer server and in locked filing cabinets only accessible to the research team.   The data 
collected in this study will be used for the purpose described in the form.  By signing this form, 
you are allowing the research team access to your medical records, which include Protected 
Health Information.  Protected Health Information (PHI) consists of any health information that 
is collected about you, which could include your medical history and new information collected 
as a result of this study.  The research team includes the individuals listed on this consent form 
and other personnel involved in this study at the University of Chicago. However, our study 
records will not include any identifiers. Your data will be thus de-identified using a coding 
system. Your behavioral data and EEG scan will be performed with a code number in the data 
field where a name would ordinarily go. Data from this study may be used in research 
publications or presentations or a registry shared between University of Chicago investigators. 
Your name and other identifying information will NOT be part of this data set. 
As part of the study, Dr. Cacioppo and her research team will report the results of your study-
related procedures and tests explained above to Valeant Pharmaceuticals. These include research 
de-identified test results. This information is being sent because that might help Valeant 
Pharmaceuticals understand the effect of Flibanserin on the female brain. The study sponsor or 
their representatives, including monitoring agencies, may also review your de-identified medical 
record. Please note that these individuals may share your health information with someone else.  
However, our study records and medical records will not include any identifiers. Your data will 
thus be coded.
Your records may be reviewed by federal agencies whose responsibility is to protect human 
subjects in research including the Food and Drug Administration (FDA) and Office of Human 
Research Protections (OHRP).  In addition, representatives of the University of Chicago, 
including the Institutional Review Board, a committee that oversees the research at the 
University of Chicago, may also view the records of the research.  If your research record is 
reviewed by any of these groups, they may also need to review your entire medical record.
If health information is shared outside the University of Chicago, the same laws that the 
University of Chicago must obey may not protect your health information.
During your participation in this study, you will have access to your medical record. Dr. 
Cacioppo is not required to release to you research information that is not part of your medical 
record.
This consent form will be kept by the research team for at least six years. The study results will 
be kept in your research record and be used by the research team indefinitely. At the time of 
study completion, either the research information not already in your medical record will be 
destroyed or information identifying you will be removed from study results.  Any research 
information in your medical record will be kept indefinitely.
Data from this study may be used in medical publications or presentations.  Your name and other 
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identifying information will be removed before this data is used.  If we wish to use identifying 
information in publications, we will ask for your approval at that time.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time.
WHAT ARE MY RIGHTS AS A PARTICIPANT?
Taking part in this study is voluntary.  If you choose not to participate in this study, your care at 
the University of Chicago/University of Chicago Medical Center will not be affected. You may 
choose not to participate at any time during the study.  Leaving the study will not affect your 
care at the University of Chicago/University of Chicago Medical Center.
If you choose to no longer be in the study and you do not want any of your future health 
information to be used, you must inform Dr. Cacioppo in writing at the address on the first page.  
Dr. Cacioppo may still use your information that was collected prior to your written notice. 
We will tell you about significant new information that may affect your willingness to stay in 
this study. 
You will be given a signed copy of this document. This consent form document does not have an 
expiration date.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
You have talked to a member of the study team about this study and you had the opportunity to 
ask questions concerning any and all aspects of the research.  If you have further questions about 
the study, you may call Dr. Cacioppo at (773) 702-6983. 
If you have a research related injury, you should immediately contact Dr. Cacioppo at (773) 702-
6983 or Dr. Grant at (773) 834-1325. 
If you have any questions concerning your rights in this research study you may contact the 
Institutional Review Board, which is concerned with the protection of subjects in research projects.  
You may reach the Committee office between 8:30 am and 5:00 pm, Monday through Friday, by 
calling (773) 702-6505 or by writing:  Institutional Review Board, University of Chicago, 5841 S. 
Maryland Ave. MC-7132, I-625, Chicago, Illinois  60637.
CONSENT
SUBJECT
The research project and the procedures associated with it have been explained to me.  The 
experimental procedures have been identified and no guarantee has been given about the possible 
results. I will receive a signed copy of this consent form for my records.
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I agree to participate in this study.  My participation is voluntary and I do not have to sign this 
form if I do not want to be part of this research study.
Signature of Subject:  
Date:  
Time:  
   AM/PM (Circle)
PERSON OBTAINING CONSENT
I have explained to 
____________________
 the nature and purpose of the study 
and the risks involved.  I have answered and will answer all questions to the best of my ability.  I 
will give a signed copy of the consent form to the subject.
Signature of Person Obtaining Consent:  
Date:  
Time:  
   AM/PM (Circle)
INVESTIGATOR/PHYSICIAN:
Signature of Investigator/Physician  
Date:  
Time:  
   AM/PM (Circle)
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