Clinical trial NCT00360529: 24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder
Official title: A Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Flibanserin 50mg Every Evening and Flibanserin 100mg Every Evening in Women With Hypoactive Sexual Desire Disorder in North America
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexual Dysfunctions, Psychological
Lead sponsor: Sprout Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2006-08-04
Enrollment: 880
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Detailed description: This trial was designed as a prospective, multicenter trial containing a 24-week, randomized, double blind, placebo controlled, parallel-group period that assessed the effects of flibanserin (maximum total daily dose: 100 mg q.d.) compared with placebo in premenopausal women with HSDD, determined by Diagnostic and Statistical Manual IV- Text Revision (DSM IV-TR®) criteria. Three hundred patients were to be randomized to each treatment group. This trial examined the safety and efficacy of flibanserin compared to placebo for 24 weeks.

Eligibility criteria: Inclusion Criteria:

1. Women who are 18 years of age and older.
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:

1. Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
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.

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Primary outcomes:
measure: Satisfying Sexual Event Monthly Change From Baseline at Final Visit
timeFrame: Baseline, Week 24
measure: Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit
timeFrame: Baseline, Week 24
measure: Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit
timeFrame: Baseline, Week 24
measure: Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit
timeFrame: Baseline, Week 24
measure: Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit
timeFrame: Baseline, Week 24
measure: Patient Benefit Evaluation
timeFrame: Week 24
Other outcomes:
Locations:
city: Mobile
country: United States
facility: 511.71.01034 Boehringer Ingelheim Investigational Site
state: Alabama
city: South Birmingham
country: United States
facility: 511.71.01042 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 511.71.01016 Boehringer Ingelheim Investigational Site
state: Arizona
city: La Mesa
country: United States
facility: 511.71.01041 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.71.01011 Boehringer Ingelheim Investigational Site
state: California
city: Westlake Village
country: United States
facility: 511.71.01027 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 511.71.01035 Boehringer Ingelheim Investigational Site
state: Colorado
city: Groton
country: United States
facility: 511.71.01010 Boehringer Ingelheim Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: 511.71.01021 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Newark
country: United States
facility: 511.71.01037 Boehringer Ingelheim Investigational Site
state: Delaware
city: Boynton Beach
country: United States
facility: 511.71.01001 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 511.71.01032 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 511.71.01014 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 511.71.01025 Boehringer Ingelheim Investigational Site
state: Florida
city: Plantation
country: United States
facility: 511.71.01006 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 511.71.01015 Boehringer Ingelheim Investigational Site
state: Georgia
city: Marietta
country: United States
facility: 511.71.01038 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 511.71.01036 Boehringer Ingelheim Investigational Site
state: Illinois
city: Evansville
country: United States
facility: 511.71.01029 Boehringer Ingelheim Investigational Site
state: Indiana
city: Renton
country: United States
facility: 511.71.01028 Boehringer Ingelheim Investigational Site
state: Indiana
city: New Orlean
country: United States
facility: 511.71.01024 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Towson
country: United States
facility: 511.71.01040 Boehringer Ingelheim Investigational Site
state: Maryland
city: Brighton
country: United States
facility: 511.71.01045 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: St. Louis
country: United States
facility: 511.71.01005 Boehringer Ingelheim Investigational Site
state: Missouri
city: Albuquerque
country: United States
facility: 511.71.01030 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Bronx
country: United States
facility: 511.71.01012 Boehringer Ingelheim Investigational Site
state: New York
city: Rochester
country: United States
facility: 511.71.01007 Boehringer Ingelheim Investigational Site
state: New York
city: New Bern
country: United States
facility: 511.71.01023 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 511.71.01002 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 511.71.01044 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 511.71.01026 Boehringer Ingelheim Investigational Site
state: Ohio
city: Edmond
country: United States
facility: 511.71.01039 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Danville
country: United States
facility: 511.71.01003 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: 511.71.01033 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 511.71.01031 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: 511.71.01022 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Germantown
country: United States
facility: 511.71.01020 Boehringer Ingelheim Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: 511.71.01017 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 511.71.01018 Boehringer Ingelheim Investigational Site
state: Texas
city: Huntington
country: United States
facility: 511.71.01008 Boehringer Ingelheim Investigational Site
state: West Virginia
city: Calgary
country: Canada
facility: 511.71.02002 Boehringer Ingelheim Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: 511.71.02006 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: 511.71.02011 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: 511.71.02007 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: 511.71.02008 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: 511.71.02012 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 511.71.02010 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: 511.71.02001 Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Burlington
country: Canada
facility: 511.71.02004 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 511.71.02013 Boehringer Ingelheim Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: 511.71.02009 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 511.71.02003 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montréal
country: Canada
facility: 511.71.02005 Boehringer Ingelheim Investigational Site
state: Quebec
city: Québec
country: Canada
facility: 511.71.02014 Boehringer Ingelheim Investigational Site
state: Quebec
Study officials:
affiliation: Sprout Pharmaceuticals
name: Sprout Pharmaceuticals
role: STUDY_CHAIR
References:
citation: 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.