12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexu… (NCT01040208) | Clinical Trial Compass
TerminatedPhase 3
12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress
Stopped: Study terminated by Sponsor for administrative reasons prior to completion
United States111 participantsStarted 2010-01
Plain-language summary
The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. Women 18-50 years of age, not postmenopausal at the Screen Visit
✓. Women with mild/remitted depressive disorder with score of \<11 on the Quick Inventory of Depressive Symptoms Self Report and \<16 on the Beck Anxiety Inventory at Screen/Baseline Visits
✓. Women with decreased sexual desire and distress present at least 4 weeks at Screen Visit as determined by the Clinical Interview for Female Sexual Dysfunction-Depression and Diagnostic and Statistical Manual IV-Text Revision (DSM IV-TR)
✓. Score of 15 or higher on the Female Sexual Distress Scale-Revised at Screen/Baseline Visits
✓. Score of 9 or lower on the Changes in Sexual Functioning Questionnaire-Female desire/interest item at Screen/Baseline Visits
✓. Patients must be taking the same Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor for 3 months and be on a stable dose at least 2 months before the Screen Visit and remain on this regimen during the trial and for 1 month after trial completion
✓. Patients must have had no treatment for Female Sexual Dysfunction 2 months before Screen Visit
✓. Patients must use medically accepted contraception method
Exclusion criteria
✕. Patients who have taken any Prohibited Medications within 30 days before Baseline Visit
✕. Patients with history of drug dependence/abuse (including alcohol) within past year
What they're measuring
1
The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.
. Patients with history of participation in a trial of another investigational drug within 1 month prior to the Screen Visit, or participation in previous flibanserin study
✕. Women with lifelong decreased sexual desire (or Hypoactive Sexual Desire Disorder), Female Sexual Arousal Disorder and/or Female Orgasmic Disorder, per DSM IV-TR criteria
✕. Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction other than Selective Serotonin Reuptake Inhibitor/Norepinephrine Serotonin Reuptake Inhibitor-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia, or Sexual Dysfunction Due to a General Medical Condition
✕. Patients who have had a hysterectomy, or are in the post menopause stage (i.e., bilateral oophorectomy, chemically induced menopause)
✕. Patients with history of pelvic inflammatory disease, urinary tract, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, significant vaginal atrophy in the 4 weeks before the Screen Visit
✕. Patients who are breastfeeding or have breastfed within 6 months prior to the Baseline Visit.