| Criteria: |
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Inclusion Criteria:
1. Women who are 18 to 50 years of age and not post-menopausal (i.e., 12 consecutive
months of amenorrhea) at the Screen Visit.
2. Women with mild or remitted depressive disorder (may also have concurrent mild
anxiety disorder or premenstrual dysphoric disorder) supported by a score of <'11' on
the Quick Inventory of Depressive Symptoms Self Report 16 and <'16' on the Beck
Anxiety Inventory at Screen and Baseline Visits.
3. Women must have decreased sexual desire and distress that has been present for at
least four weeks at Screen Visit as determined by the Clinical Interview for Female
Sexual Dysfunction - Depression and Diagnostic and Statistical Manual IV-Text
Revision criteria.
4. A score of '15' or higher on the Female Sexual Distress Scale-Revised at the Screen
and Baseline Visits.
5. A score of '9' or lower on the Changes in Sexual Functioning Questionnaire-Female
desire/interest item at the Screen and Baseline Visits.
6. Patients must be taking the same Selective Serotonin Reuptake Inhibitor or
Norepinephrine Serotonin Reuptake Inhibitor for three months and be on a stable dose
for at least two months before the Screen Visit and plan to remain on this same
Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor
through out the trial and for one month after the completion of the trial.
7. Patients must have had no treatment for Female Sexual Dysfunction in the two months
before the start of the Screen Visit.
8. Patients must use a medically acceptable method of contraception.
9. Patients must be in a stable, monogamous, heterosexual relationship that is secure
and communicative, for at least twelve months prior to the Screen Visit, according to
the Clinical Interview for Female Sexual Dysfunction - Depression. The relationship
is to be with the same partner who is sexually functional, both psychologically and
physically, and the partner is expected to be physically present.
Exclusion Criteria:
Clinically relevant conditions which might interfere with the patient's ability to
participate in the trial include, but are not limited to the following:
1. Patients who have taken any Prohibited Medications, within 30 days before the
Baseline Visit.
2. Patients with a history of drug dependence or abuse (including alcohol, as defined in
Diagnostic and Statistical Manual IV-Text Revision or in the opinion of the
investigator) within the past 12 months.
3. Patients with a history of participation in a trial of another investigational
medication within one month prior to the Screen Visit, or participation in any
previous clinical trial of flibanserin.
4. Women with lifelong: decreased sexual desire (or Hypoactive Sexual Desire Disorder),
Female Sexual Arousal Disorder and/or Female Orgasmic Disorder, according to
Diagnostic and Statistical Manual IV-Text Revision criteria.
5. Patients who meet Diagnostic and Statistical Manual IV-Text Revision criteria for
Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction other than Selective
Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor-Induced
Sexual Dysfunction, Dyspareunia (not caused by inadequate foreplay stimulation or
alleviated by lubricants), Vaginismus, Gender Identity Disorder, Paraphilia, or for
Sexual Dysfunction Due to a General Medical Condition other than Sexual Dysfunction
Due to Depression.
6. Patients who have had a hysterectomy (with or without bilateral oophorectomy), or are
in the post menopause stage (i.e., had bilateral oophorectomy or have chemical
induced [e.g., chemotherapy] menopause).
7. Patients with a history of pelvic inflammatory disease, urinary tract or vaginal
infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant
vaginal atrophy in the preceding four weeks before the Screen Visit.
8. Patients who are breastfeeding or have breastfed within the six months prior to the
Baseline Visit.
9. Patients who are pregnant (by serum pregnancy test at the Screen Visit) or have been
pregnant within the six months prior to the Baseline Visit.
10. Patients with a current episode of Depressive Disorder (may also have concurrent mild
Anxiety Disorder) not adequately controlled during the last two months and/or with a
score of <11 on the Quick Inventory of Depressive Symptoms Self Report 16 and/or a
score of <16 on the Beck Anxiety Inventory at Screen and/or Baseline Visits.
11. Patients with a history of suicide attempt within the last 12 months or currently
active suicidal ideation. The investigator must assess the patient's history of
suicide attempt/ideation and determine if the patient is "at risk" before entering
the trial.
12. Patients with a history of any other psychiatric disorders that could impact sexual
function, risks patient's safety, or may impact compliance. Axis I disorders (except
anxiety symptoms and disorders) including eating disorders are excluded. Axis II
disorders (except mental retardation and anti-social personality disorder) are
allowed.
13. Patients with clinically significant cardiac, neurologic, hepatic, renal,
hematologic, respiratory, gastrointestinal, immunological, and endocrine disease.
14. Patients with a history of breast cancer and/or other cancer within the last 5 years,
other than non-invasive, previously resected skin cancer. |