12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress

Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Sexual Dysfunctions, Psychological
• Intervention / Treatment: Drug: flibanserin 50 mg to 100 mg qhs; Drug: flibanserin 100 mg qhs; Drug: placebo 2 tablets qhs

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92636
      • Clinical Innovations
    • Fresno, California, United States, 93720
      • Mood & Anxiety Research
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
    • Riverside, California, United States, 92506
      • Clinical Innovations
    • Sherman Oaks, California, United States, 91403
      • Schuster Medical Research
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80204
      • Western Affiliated Research Institute
    • Denver, Colorado, United States, 80239
      • Radiant Research
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Ali Kashfi
    • Fort Myers, Florida, United States, 33912
      • Gulf Coast Clinical Research
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solutions
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • Winter Park, Florida, United States, 32789
      • Kolin Research Group
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Atlanta Institute of Medicine & Research
    • Atlanta, Georgia, United States, 30328
      • Comprehensive Neuroscience
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Chicago Research Center
    • Livertyville, Illinois, United States, 60048
      • Capstone Clinical Research
    • Skokie, Illinois, United States, 60076
      • Psychiatric Medicine Associates
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Clinco
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Clinical Trials Technology
  • Maryland
    • Baltimore, Maryland, United States, 21285
      • Sheppard Pratt Hospital
  • Massachusetts
    • Haverhill, Massachusetts, United States, 01830
      • ActivMed Practices and Research
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Millennium Psychiatric Associates
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience
  • New York
    • Brooklyn, New York, United States, 11235
      • Social Psychiatry Research Institute
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research
    • New York, New York, United States, 10023
      • Medical and Behavioral Health Research
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Dayton, Ohio, United States, 45408
      • Midwest Clinical Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions
  • Texas
    • Austin, Texas, United States, 78756
      • Future Search Trials
    • Irving, Texas, United States, 75062
      • Mary Ann Knesevich
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
    • San Antonio, Texas, United States, 78240
      • San Antonio Psychiatric Research Center
  • Virginia
    • Richmond, Virginia, United States, 23230
      • Alliance Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

1. Women 18-50 years of age, not postmenopausal at the Screen Visit
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:

Conditions which may interfere with the ability to participate include, but are not limited to:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: flibanserin 50 mg to 100 mg qhs; 50 to 100mg qhs
Experimental: flibanserin 100 mg qhs; Patient to receive 2 flibanserin tablets of 50 mg qhs	Drug: flibanserin 100 mg qhs; 100mg qhs
Experimental: placebo 2 tablets qhs; Patient to receive 2 placebo tablets of 50 mg qhs	Drug: placebo 2 tablets qhs; 50 mg placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.	17 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)	12 weeks
The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)	12 weeks

Collaborators and Investigators

• Sponsor: Sprout Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: December 28, 2009
• First Submitted That Met QC Criteria: December 28, 2009
• First Posted (Estimate): December 29, 2009

Study Record Updates

• Last Update Posted (Estimate): August 24, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: 511.114