12 Week Safety Trial of Flibanserin in Depressed Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire and Distress

This study has been terminated.
(Study terminated by Sponsor for administrative reasons prior to completion of all study visits)
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01040208
First received: December 28, 2009
Last updated: March 2, 2012
Last verified: March 2012
  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 2
Drug: placebo
Drug: flibanserin 1
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 ]
  • Change from baseline on blood pressure and pulse, weight. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • .Change from baseline on laboratory and electrocardiogram values. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline on mean score for the 16 Item Quick Inventory of Depressive Symptoms - Self Report. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline on mean score of Beck Anxiety Inventory. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • The occurrence of suicidal behavior or ideation as a change from baseline on the Columbia-Suicide Severity Rating Scale. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 111
Study Start Date: January 2010
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 1
50 mg qhs for 14 days then 100mg qhs
Experimental: flibanserin 100 mg qhs
Patient to receive 2 flibanserin tablets of 50 mg qhs
Drug: flibanserin 2
100mg qhs
Experimental: placebo 2 tablets qhs
Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
Drug: placebo
2 tablets qhs

  Eligibility

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

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.
  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

No publications provided

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01040208     History of Changes
Other Study ID Numbers: 511.114
Study First Received: December 28, 2009
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Sexual Dysfunctions, Psychological
Behavioral Symptoms
Sexual and Gender Disorders
Mental Disorders
Serotonin
Flibanserin
Norepinephrine
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin 5-HT2 Receptor Antagonists
Neurotransmitter Uptake Inhibitors
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014