24-Week Placebo-Controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder

Sexual Dysfunctions, Psychological Clinical Trial

Official title:

A Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Every Evening and Flibanserin 100 Milligrams Every Evening in Women With Hypoactive Sexual Desire Disorder in North America

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360529
• Other study ID #: 511.71
• Secondary ID: VIOLET
• Status: Completed
• Phase: Phase 3
• First received: August 3, 2006
• Last updated: April 24, 2009
• Start date: July 2006

Study information

• Verified date: April 2009
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada (TPD)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 886
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 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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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexual Dysfunctions, Psychological

Intervention

Drug:
• flibanserin

Locations

Country	Name	City	State
Canada	511.71.02004 Boehringer Ingelheim Investigational Site	Burlington	Ontario
Canada	511.71.02002 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	511.71.02001 Boehringer Ingelheim Investigational Site	Halifax	Nova Scotia
Canada	511.71.02006 Boehringer Ingelheim Investigational Site	Kelowna	British Columbia
Canada	511.71.02013 Boehringer Ingelheim Investigational Site	London	Ontario
Canada	511.71.02005 Boehringer Ingelheim Investigational Site	Montréal	Quebec
Canada	511.71.02009 Boehringer Ingelheim Investigational Site	Oshawa	Ontario
Canada	511.71.02003 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	511.71.02014 Boehringer Ingelheim Investigational Site	Québec	Quebec
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
United States	511.71.01030 Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	511.71.01015 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	511.71.01001 Boehringer Ingelheim Investigational Site	Boynton Beach	Florida
United States	511.71.01045 Boehringer Ingelheim Investigational Site	Brighton	Massachusetts
United States	511.71.01012 Boehringer Ingelheim Investigational Site	Bronx	New York
United States	511.71.01036 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	511.71.01002 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	511.71.01044 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	511.71.01032 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	511.71.01026 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	511.71.01003 Boehringer Ingelheim Investigational Site	Danville	Pennsylvania
United States	511.71.01035 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	511.71.01039 Boehringer Ingelheim Investigational Site	Edmond	Oklahoma
United States	511.71.01029 Boehringer Ingelheim Investigational Site	Evansville	Indiana
United States	511.71.01020 Boehringer Ingelheim Investigational Site	Germantown	Tennessee
United States	511.71.01010 Boehringer Ingelheim Investigational Site	Groton	Connecticut
United States	511.71.01008 Boehringer Ingelheim Investigational Site	Huntington	West Virginia
United States	511.71.01041 Boehringer Ingelheim Investigational Site	La Mesa	California
United States	511.71.01038 Boehringer Ingelheim Investigational Site	Marietta	Georgia
United States	511.71.01014 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	511.71.01034 Boehringer Ingelheim Investigational Site	Mobile	Alabama
United States	511.71.01022 Boehringer Ingelheim Investigational Site	Mt. Pleasant	South Carolina
United States	511.71.01023 Boehringer Ingelheim Investigational Site	New Bern	North Carolina
United States	511.71.01021 Boehringer Ingelheim Investigational Site	New Britain	Connecticut
United States	511.71.01024 Boehringer Ingelheim Investigational Site	New Orlean	Louisiana
United States	511.71.01037 Boehringer Ingelheim Investigational Site	Newark	Delaware
United States	511.71.01025 Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	511.71.01033 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
United States	511.71.01016 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	511.71.01031 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	511.71.01006 Boehringer Ingelheim Investigational Site	Plantation	Florida
United States	511.71.01028 Boehringer Ingelheim Investigational Site	Renton	Indiana
United States	511.71.01007 Boehringer Ingelheim Investigational Site	Rochester	New York
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	511.71.01011 Boehringer Ingelheim Investigational Site	San Diego	California
United States	511.71.01042 Boehringer Ingelheim Investigational Site	South Birmingham	Alabama
United States	511.71.01005 Boehringer Ingelheim Investigational Site	St. Louis	Missouri
United States	511.71.01040 Boehringer Ingelheim Investigational Site	Towson	Maryland
United States	511.71.01027 Boehringer Ingelheim Investigational Site	Westlake Village	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoints are the increases in how often women have satisfying sexual events and in how much their sexual desire increases. Both are measured by making daily entries in an electronic diary.		24 weeks
Secondary	Changes from baseline on diary sexual distress question and on a small number of patient-completed questions/questionnaires		24 weeks