24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder
NCT ID: NCT00360529
Last Updated: 2016-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
880 participants
INTERVENTIONAL
2006-07-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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fibanserin
flibanserin 50 mg q.h.s.
flibanserin
flibanserin placebo versus 50 mg qhs versus 100 mg qhs
flibanserin
flibanserin 100 mg q.h.s.
flibanserin
flibanserin placebo versus 50 mg qhs versus 100 mg qhs
placebo
placebo q.h.s.
flibanserin
flibanserin placebo versus 50 mg qhs versus 100 mg qhs
Interventions
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flibanserin
flibanserin placebo versus 50 mg qhs versus 100 mg qhs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
3. Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
4. Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
5. Patients must be willing and able to use an electronic diary (eDiary) on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
6. At the Baseline Visit, patients must have complied with eDiary use adequately.
7. Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
8. Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
9. In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
10. Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
11. Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.
Exclusion Criteria
2. Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
3. Patients with a history of drug dependence or abuse within the past one year.
4. Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
5. 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.
6. Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
7. Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
8. Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
9. Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
10. Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
11. Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
12. Patients with a history of Major Depressive Disorder within 6 months prior the Screen Visit, a score indicating depression on a depression scale, a history of suicide attempt, or current suicidal ideation evident at the Screen or Baseline Visit.
13. Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance.
\<truncated\>
18 Years
FEMALE
No
Sponsors
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Sprout Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sprout Pharmaceuticals
Role: STUDY_CHAIR
Sprout Pharmaceuticals
Locations
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511.71.01034 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
511.71.01042 Boehringer Ingelheim Investigational Site
South Birmingham, Alabama, United States
511.71.01016 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
511.71.01041 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
511.71.01011 Boehringer Ingelheim Investigational Site
San Diego, California, United States
511.71.01027 Boehringer Ingelheim Investigational Site
Westlake Village, California, United States
511.71.01035 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
511.71.01010 Boehringer Ingelheim Investigational Site
Groton, Connecticut, United States
511.71.01021 Boehringer Ingelheim Investigational Site
New Britain, Connecticut, United States
511.71.01037 Boehringer Ingelheim Investigational Site
Newark, Delaware, United States
511.71.01001 Boehringer Ingelheim Investigational Site
Boynton Beach, Florida, United States
511.71.01032 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
511.71.01014 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
511.71.01025 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
511.71.01006 Boehringer Ingelheim Investigational Site
Plantation, Florida, United States
511.71.01015 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
511.71.01038 Boehringer Ingelheim Investigational Site
Marietta, Georgia, United States
511.71.01036 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
511.71.01029 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
511.71.01028 Boehringer Ingelheim Investigational Site
Renton, Indiana, United States
511.71.01024 Boehringer Ingelheim Investigational Site
New Orlean, Louisiana, United States
511.71.01040 Boehringer Ingelheim Investigational Site
Towson, Maryland, United States
511.71.01045 Boehringer Ingelheim Investigational Site
Brighton, Massachusetts, United States
511.71.01005 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
511.71.01030 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
511.71.01007 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
511.71.01012 Boehringer Ingelheim Investigational Site
The Bronx, New York, United States
511.71.01023 Boehringer Ingelheim Investigational Site
New Bern, North Carolina, United States
511.71.01002 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
511.71.01044 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
511.71.01026 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
511.71.01039 Boehringer Ingelheim Investigational Site
Edmond, Oklahoma, United States
511.71.01003 Boehringer Ingelheim Investigational Site
Danville, Pennsylvania, United States
511.71.01033 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
511.71.01031 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
511.71.01022 Boehringer Ingelheim Investigational Site
Mt. Pleasant, South Carolina, United States
511.71.01020 Boehringer Ingelheim Investigational Site
Germantown, Tennessee, United States
511.71.01017 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
511.71.01018 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
511.71.01008 Boehringer Ingelheim Investigational Site
Huntington, West Virginia, United States
511.71.02002 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
511.71.02006 Boehringer Ingelheim Investigational Site
Kelowna, British Columbia, Canada
511.71.02011 Boehringer Ingelheim Investigational Site
Surrey, British Columbia, Canada
511.71.02007 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
511.71.02008 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
511.71.02012 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
511.71.02010 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
511.71.02001 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
511.71.02004 Boehringer Ingelheim Investigational Site
Burlington, Ontario, Canada
511.71.02013 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
511.71.02009 Boehringer Ingelheim Investigational Site
Oshawa, Ontario, Canada
511.71.02003 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
511.71.02005 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
511.71.02014 Boehringer Ingelheim Investigational Site
Québec, Quebec, Canada
Countries
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References
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Derogatis LR, Komer L, Katz M, Moreau M, Kimura T, Garcia M Jr, Wunderlich G, Pyke R; VIOLET Trial Investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med. 2012 Apr;9(4):1074-85. doi: 10.1111/j.1743-6109.2011.02626.x. Epub 2012 Jan 16.
Other Identifiers
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VIOLET
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
511.71
Identifier Type: -
Identifier Source: org_study_id
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