12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress
NCT ID: NCT01040208
Last Updated: 2016-08-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
111 participants
INTERVENTIONAL
2010-01-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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flibanserin 50 mg to 100 mg qhs
Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
flibanserin 50 mg to 100 mg qhs
50 to 100mg qhs
flibanserin 100 mg qhs
Patient to receive 2 flibanserin tablets of 50 mg qhs
flibanserin 100 mg qhs
100mg qhs
placebo 2 tablets qhs
Patient to receive 2 placebo tablets of 50 mg qhs
placebo 2 tablets qhs
50 mg placebo
Interventions
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flibanserin 50 mg to 100 mg qhs
50 to 100mg qhs
flibanserin 100 mg qhs
100mg qhs
placebo 2 tablets qhs
50 mg placebo
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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)
4. Score of 15 or higher on the Female Sexual Distress Scale-Revised at Screen/Baseline Visits
5. Score of 9 or lower on the Changes in Sexual Functioning Questionnaire-Female desire/interest item at Screen/Baseline Visits
6. 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
7. Patients must have had no treatment for Female Sexual Dysfunction 2 months before Screen Visit
8. Patients must use medically accepted contraception method
9. Patients must be in a secure, stable, monogamous, heterosexual relationship at least 12 months prior to Screen Visit, according to the Clinical Interview for Female Sexual Dysfunction-Depression
Exclusion Criteria
1. Patients who have taken any Prohibited Medications within 30 days before Baseline Visit
2. Patients with history of drug dependence/abuse (including alcohol) within past year
3. 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
4. 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
5. 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
6. Patients who have had a hysterectomy, or are in the post menopause stage (i.e., bilateral oophorectomy, chemically induced menopause)
7. 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
8. Patients who are breastfeeding or have breastfed within 6 months prior to the Baseline Visit.
9. Patients who are pregnant (by serum pregnancy test) or have been pregnant within 6 months prior to the Baseline Visit
10. Patients with current Depressive Disorder (may have concurrent mild Anxiety Disorder) not adequately controlled during the last 2 months and/or with a score of \<11 on the Quick Inventory of Depressive Symptoms Self Report and/or a score of \<16 on the Beck Anxiety Inventory at Screen and/or Baseline Visits
11. Patients with history of suicide attempt within the last year or current suicidal ideation. Investigator must assess history of suicidality to determine if patient is at risk before entering the trial
12. Patients with history of other psychiatric disorders that could impact sexual function, risks patient safety, or may impact compliance. Axis I disorders (except anxiety symptoms and disorders) are excluded. Axis II disorders are allowed
13. Patients with significant cardiac, neurologic, hepatic, renal, hematologic, respiratory, gastrointestinal, immunological, endocrine disease
14. Patients with history of breast cancer or other cancer within the last 5 years, other than non-invasive, previously resected skin cancer
18 Years
50 Years
FEMALE
No
Sponsors
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Sprout Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Clinical Innovations
Costa Mesa, California, United States
Mood & Anxiety Research
Fresno, California, United States
Synergy Clinical Research Center
National City, California, United States
Clinical Innovations
Riverside, California, United States
Schuster Medical Research
Sherman Oaks, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Western Affiliated Research Institute
Denver, Colorado, United States
Radiant Research
Denver, Colorado, United States
Ali Kashfi
Altamonte Springs, Florida, United States
Gulf Coast Clinical Research
Fort Myers, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Kolin Research Group
Winter Park, Florida, United States
Atlanta Institute of Medicine & Research
Atlanta, Georgia, United States
Comprehensive Neuroscience
Atlanta, Georgia, United States
Chicago Research Center
Chicago, Illinois, United States
Capstone Clinical Research
Livertyville, Illinois, United States
Psychiatric Medicine Associates
Skokie, Illinois, United States
Clinco
Terre Haute, Indiana, United States
Clinical Trials Technology
Prairie Village, Kansas, United States
Sheppard Pratt Hospital
Baltimore, Maryland, United States
ActivMed Practices and Research
Haverhill, Massachusetts, United States
Millennium Psychiatric Associates
Creve Coeur, Missouri, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Neurobehavioral Research
Cedarhurst, New York, United States
Bioscience Research
Mount Kisco, New York, United States
Medical and Behavioral Health Research
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
MIdwest Clinical Research Center
Dayton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Suburban Research Associates
Media, Pennsylvania, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, United States
Future Search Trials
Austin, Texas, United States
Mary Ann Knesevich
Irving, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
San Antonio Psychiatric Research Center
San Antonio, Texas, United States
Alliance Research Group
Richmond, Virginia, United States
Countries
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Other Identifiers
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511.114
Identifier Type: -
Identifier Source: org_study_id
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