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

NCT01040208 | Terminated Phase 3 Results DMC

• 1 other identifier: 511.114
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 42

Brief 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.

Conditions

Sexual Dysfunctions, Psychological; Depression

Outcome Measures

Primary Outcomes (1)

• The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.

  17 weeks

Secondary Outcomes (2)

• 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

Study Arms (3)

flibanserin 50 mg to 100 mg qhs

EXPERIMENTAL

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

flibanserin 100 mg qhs

EXPERIMENTAL

Patient to receive 2 flibanserin tablets of 50 mg qhs

Drug: flibanserin 100 mg qhs

placebo 2 tablets qhs

EXPERIMENTAL

Patient to receive 2 placebo tablets of 50 mg qhs

Drug: placebo 2 tablets qhs

Interventions

flibanserin 50 mg to 100 mg qhs DRUG

50 to 100mg qhs

flibanserin 50 mg to 100 mg qhs

flibanserin 100 mg qhs DRUG

100mg qhs

flibanserin 100 mg qhs

placebo 2 tablets qhs DRUG

50 mg placebo

placebo 2 tablets qhs

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18-50 years of age, not postmenopausal at the Screen Visit
• 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
• 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)
• Score of 15 or higher on the Female Sexual Distress Scale-Revised at Screen/Baseline Visits
• Score of 9 or lower on the Changes in Sexual Functioning Questionnaire-Female desire/interest item at Screen/Baseline Visits
• 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
• Patients must have had no treatment for Female Sexual Dysfunction 2 months before Screen Visit
• Patients must use medically accepted contraception method
• 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

You may not qualify if:

• Conditions which may interfere with the ability to participate include, but are not limited to:
• Patients who have taken any Prohibited Medications within 30 days before Baseline Visit
• Patients with history of drug dependence/abuse (including alcohol) within past year
• 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
• 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
• 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
• Patients who have had a hysterectomy, or are in the post menopause stage (i.e., bilateral oophorectomy, chemically induced menopause)
• 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
• Patients who are breastfeeding or have breastfed within 6 months prior to the Baseline Visit.
• Patients who are pregnant (by serum pregnancy test) or have been pregnant within 6 months prior to the Baseline Visit
• 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
• 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
• 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
• Patients with significant cardiac, neurologic, hepatic, renal, hematologic, respiratory, gastrointestinal, immunological, endocrine disease
• Patients with history of breast cancer or other cancer within the last 5 years, other than non-invasive, previously resected skin cancer

Sponsors & Collaborators

• Sprout Pharmaceuticals, Inc: lead

Study Sites (42)

Clinical Innovations

Costa Mesa, California, 92636, United States

Location

Mood & Anxiety Research

Fresno, California, 93720, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Clinical Innovations

Riverside, California, 92506, United States

Location

Schuster Medical Research

Sherman Oaks, California, 91403, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Western Affiliated Research Institute

Denver, Colorado, 80204, United States

Location

Radiant Research

Denver, Colorado, 80239, United States

Location

Ali Kashfi

Altamonte Springs, Florida, 32701, United States

Location

Gulf Coast Clinical Research

Fort Myers, Florida, 33912, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Clinical Neuroscience Solutions

Jacksonville, Florida, 32216, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32806, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Kolin Research Group

Winter Park, Florida, 32789, United States

Location

Atlanta Institute of Medicine & Research

Atlanta, Georgia, 30328, United States

Location

Comprehensive Neuroscience

Atlanta, Georgia, 30328, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Capstone Clinical Research

Livertyville, Illinois, 60048, United States

Location

Psychiatric Medicine Associates

Skokie, Illinois, 60076, United States

Location

Clinco

Terre Haute, Indiana, 47802, United States

Location

Clinical Trials Technology

Prairie Village, Kansas, 66206, United States

Location

Sheppard Pratt Hospital

Baltimore, Maryland, 21285, United States

Location

ActivMed Practices and Research

Haverhill, Massachusetts, 01830, United States

Location

Millennium Psychiatric Associates

Creve Coeur, Missouri, 63141, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

Albuquerque Neuroscience

Albuquerque, New Mexico, 87109, United States

Location

Social Psychiatry Research Institute

Brooklyn, New York, 11235, United States

Location

Neurobehavioral Research

Cedarhurst, New York, 11516, United States

Location

Bioscience Research

Mount Kisco, New York, 10549, United States

Location

Medical and Behavioral Health Research

New York, New York, 10023, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MIdwest Clinical Research Center

Dayton, Ohio, 45408, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

CRI Worldwide

Philadelphia, Pennsylvania, 19139, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

Future Search Trials

Austin, Texas, 78756, United States

Location

Mary Ann Knesevich

Irving, Texas, 75062, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

San Antonio Psychiatric Research Center

San Antonio, Texas, 78240, United States

Location

Alliance Research Group

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Depression

Interventions

flibanserin

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Krista Barbour
• Organization: Sprout Pharmaceuticals

kbarbour@sproutpharma.com

9198820850

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2009
• First Posted: December 29, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 24, 2016
• Results First Posted: August 24, 2016

Record last verified: 2016-07

Locations

US (42)