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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01040208
Other study ID # 511.114
Secondary ID
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. completion date
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


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
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