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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01040208
• Other study ID #: 511.114
• Status: Terminated
• Phase: Phase 3
• First received: December 28, 2009
• Last updated: March 2, 2012
• Start date: January 2010

Study information

• Verified date: March 2012
• Source: Sprout Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• flibanserin 2
100mg qhs
• placebo
2 tablets qhs
• flibanserin 1
50 mg qhs for 14 days then 100mg qhs

Locations

Country	Name	City	State
United States	511.114.01011 Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	511.114.01029 Boehringer Ingelheim Investigational Site	Altamonte Springs	Florida
United States	511.114.01005 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	511.114.01036 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	511.114.01019 Boehringer Ingelheim Investigational Site	Austin	Texas
United States	511.114.01012 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	511.114.01045 Boehringer Ingelheim Investigational Site	Brooklyn	New York
United States	511.114.01006 Boehringer Ingelheim Investigational Site	Cedarhurst	New York
United States	511.114.01032 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	511.114.01001 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	511.114.01061 Boehringer Ingelheim Investigational Site	Costa Mesa	California
United States	511.114.01048 Boehringer Ingelheim Investigational Site	Creve Coeur	Missouri
United States	511.114.01009 Boehringer Ingelheim Investigational Site	Dayton	Ohio
United States	511.114.01015 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	511.114.01034 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	511.114.01033 Boehringer Ingelheim Investigational Site	Fort Myers	Florida
United States	511.114.01046 Boehringer Ingelheim Investigational Site	Fresno	California
United States	511.114.01027 Boehringer Ingelheim Investigational Site	Gainesville	Florida
United States	511.114.01060 Boehringer Ingelheim Investigational Site	Haver Hill	Massachusetts
United States	511.114.01043 Boehringer Ingelheim Investigational Site	Irving	Texas
United States	511.114.01028 Boehringer Ingelheim Investigational Site	Jacksonville	Florida
United States	511.114.01022 Boehringer Ingelheim Investigational Site	Livertyville	Illinois
United States	511.114.01026 Boehringer Ingelheim Investigational Site	Media	Pennsylvania
United States	511.114.01002 Boehringer Ingelheim Investigational Site	Memphis	Tennessee
United States	511.114.01052 Boehringer Ingelheim Investigational Site	Mount Kisco	New York
United States	511.114.01003 Boehringer Ingelheim Investigational Site	National City	California
United States	511.114.01021 Boehringer Ingelheim Investigational Site	New York	New York
United States	511.114.01041 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma
United States	511.114.01024 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	511.114.01023 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
United States	511.114.01040 Boehringer Ingelheim Investigational Site	Prairie Village	Kansas
United States	511.114.01051 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	511.114.01013 Boehringer Ingelheim Investigational Site	Riverside	California
United States	511.114.01008 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	511.114.01031 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	511.114.01037 Boehringer Ingelheim Investigational Site	Sherman Oaks	California
United States	511.114.01042 Boehringer Ingelheim Investigational Site	Skokie	Illinois
United States	511.114.01039 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	511.114.01025 Boehringer Ingelheim Investigational Site	Terre Haute	Indiana
United States	511.114.01057 Boehringer Ingelheim Investigational Site	Toms River	New Jersey
United States	511.114.01049 Boehringer Ingelheim Investigational Site	Walnut Creek	California
United States	511.114.01030 Boehringer Ingelheim Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sprout Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary safety endpoint is the occurrence of adverse events during the treatment and post treatment period.		17 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Change from baseline on blood pressure and pulse, weight.		12 weeks	Yes
Secondary	.Change from baseline on laboratory and electrocardiogram values.		12 weeks	Yes
Secondary	Change from baseline on mean score for the 16 Item Quick Inventory of Depressive Symptoms - Self Report.		12 weeks	Yes
Secondary	Change from baseline on mean score of Beck Anxiety Inventory.		12 weeks	Yes
Secondary	The occurrence of suicidal behavior or ideation as a change from baseline on the Columbia-Suicide Severity Rating Scale.		12 weeks	Yes