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

This study has been terminated.
(Study terminated by Sponsor for administrative reasons prior to completion)
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01040208
First received: December 28, 2009
Last updated: July 14, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Sexual Dysfunctions, Psychological
Depression
Drug: flibanserin 50 mg to 100 mg qhs
Drug: flibanserin 100 mg qhs
Drug: placebo 2 tablets qhs
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire

Resource links provided by NLM:


Further study details as provided by Sprout Pharmaceuticals, Inc:

Primary Outcome Measures:
  • The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period. [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 111
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040208

  Show 42 Study Locations
Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01040208     History of Changes
Other Study ID Numbers: 511.114 
Study First Received: December 28, 2009
Results First Received: June 6, 2013
Last Updated: July 14, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016