A Twenty Four Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

Sexual Dysfunctions, Psychological Clinical Trial

Official title:

Best Tolerability: 50mg Twice Daily Versus 100 mg in the Evening Versus 25 mg Twice Daily Versus Placebo in Younger Women in North America

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360555
• Other study ID #: 511.75
• Status: Completed
• Phase: Phase 3
• First received: August 3, 2006
• Last updated: March 6, 2012
• Start date: July 2006

Study information

• Verified date: March 2012
• Source: Sprout Pharmaceuticals, Inc
• 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 Disorder (HSDD) that meets standard diagnostic criteria.

Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1584
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

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.

12. A score of 15 or higher on the FSDS-R at 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.

14. Patients who have started psychotherapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexual Dysfunctions, Psychological

Intervention

Drug:
• flibanserin
placebo
• flibanserin
25 mg
• flibaserin
50 mg qhs/bid
• flibanserin
50 mg bid/100qhs

Locations

Country	Name	City	State
Canada	511.75.02010 Boehringer Ingelheim Investigational Site	Barrie	Ontario
Canada	511.75.02008 Boehringer Ingelheim Investigational Site	Coquitlam	British Columbia
Canada	511.75.02011 Boehringer Ingelheim Investigational Site	London	Ontario
Canada	511.75.02005 Boehringer Ingelheim Investigational Site	Mount Pearl	Newfoundland and Labrador
Canada	511.75.02002 Boehringer Ingelheim Investigational Site	North Vancouver	British Columbia
Canada	511.75.02001 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	511.75.02012 Boehringer Ingelheim Investigational Site	Quebec
Canada	511.75.02014 Boehringer Ingelheim Investigational Site	Quebec
Canada	511.75.02003 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	511.75.02009 Boehringer Ingelheim Investigational Site	Sherbrooke	Quebec
Canada	511.75.02007 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	511.75.02013 Boehringer Ingelheim Investigational Site	Trois-Rivières	Quebec
Canada	511.75.02004 Boehringer Ingelheim Investigational Site	Woodstock	New Brunswick
United States	511.75.01065 Boehringer Ingelheim Investigational Site	Aurora	Colorado
United States	511.75.01013 Boehringer Ingelheim Investigational Site	Austin	Texas
United States	511.75.01069 Boehringer Ingelheim Investigational Site	Beachwood	Ohio
United States	511.75.01017 Boehringer Ingelheim Investigational Site	Berkeley	California
United States	511.75.01043 Boehringer Ingelheim Investigational Site	Bingham Farms	Michigan
United States	511.75.01015 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	511.75.01037 Boehringer Ingelheim Investigational Site	Chapel Hill	North Carolina
United States	511.75.01007 Boehringer Ingelheim Investigational Site	Charlottesville	Virginia
United States	511.75.01025 Boehringer Ingelheim Investigational Site	Chaska	Minnesota
United States	511.75.01024 Boehringer Ingelheim Investigational Site	Chesterfield	Missouri
United States	511.75.01023 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	511.75.01012 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	511.75.01071 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	511.75.01038 Boehringer Ingelheim Investigational Site	Cleveland	Ohio
United States	511.75.01048 Boehringer Ingelheim Investigational Site	Cleveland	Ohio
United States	511.75.01067 Boehringer Ingelheim Investigational Site	Columbia	South Carolina
United States	511.75.01061 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	511.75.01066 Boehringer Ingelheim Investigational Site	Coral Gables	Florida
United States	511.75.01027 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	511.75.01014 Boehringer Ingelheim Investigational Site	Encinitas	California
United States	511.75.01003 Boehringer Ingelheim Investigational Site	Englewood	Colorado
United States	511.75.01052 Boehringer Ingelheim Investigational Site	Eugene	Oregon
United States	511.75.01042 Boehringer Ingelheim Investigational Site	Fair Oaks	California
United States	511.75.01040 Boehringer Ingelheim Investigational Site	Fort Meyers	Florida
United States	511.75.01031 Boehringer Ingelheim Investigational Site	Fort Wayne	Indiana
United States	511.75.01044 Boehringer Ingelheim Investigational Site	Fort Worth	Texas
United States	511.75.01001 Boehringer Ingelheim Investigational Site	Gainesville	Florida
United States	511.75.01070 Boehringer Ingelheim Investigational Site	Greenville	South Carolina
United States	511.75.01062 Boehringer Ingelheim Investigational Site	Hollywood	Florida
United States	511.75.01011 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	511.75.01022 Boehringer Ingelheim Investigational Site	Irvine	California
United States	511.75.01018 Boehringer Ingelheim Investigational Site	Jenkintown	Pennsylvania
United States	511.75.01009 Boehringer Ingelheim Investigational Site	Kansas City	Missouri
United States	511.75.01064 Boehringer Ingelheim Investigational Site	Knoxville	Tennessee
United States	511.75.01005 Boehringer Ingelheim Investigational Site	La Jolla	California
United States	511.75.01050 Boehringer Ingelheim Investigational Site	Lafayette	Louisiana
United States	511.75.01060 Boehringer Ingelheim Investigational Site	Las Vegas	Nevada
United States	511.75.01063 Boehringer Ingelheim Investigational Site	Little Rock	Arkansas
United States	511.75.01059 Boehringer Ingelheim Investigational Site	Medfod	Oregon
United States	511.75.01036 Boehringer Ingelheim Investigational Site	Middleton	Wisconsin
United States	511.75.01028 Boehringer Ingelheim Investigational Site	Mobile	Alabama
United States	511.75.01049 Boehringer Ingelheim Investigational Site	Nashville	Tennessee
United States	511.75.01004 Boehringer Ingelheim Investigational Site	New Brunswick	New Jersey
United States	511.75.01057 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	511.75.01032 Boehringer Ingelheim Investigational Site	Ocala	Florida
United States	511.75.01047 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	511.75.01073 Boehringer Ingelheim Investigational Site	Palm Bay	Florida
United States	511.75.01051 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	511.75.01021 Boehringer Ingelheim Investigational Site	Portland	Oregon
United States	511.75.01046 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	511.75.01053 Boehringer Ingelheim Investigational Site	Sacremento	California
United States	511.75.01055 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	511.75.01045 Boehringer Ingelheim Investigational Site	San Diego	California
United States	511.75.01006 Boehringer Ingelheim Investigational Site	Sandy Springs	Georgia
United States	511.75.01035 Boehringer Ingelheim Investigational Site	Sarasota	Florida
United States	511.75.01019 Boehringer Ingelheim Investigational Site	Seattle	Washington
United States	511.75.01010 Boehringer Ingelheim Investigational Site	South Miami	Florida
United States	511.75.01041 Boehringer Ingelheim Investigational Site	St. Petersburg	Florida
United States	511.75.01033 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	511.75.01020 Boehringer Ingelheim Investigational Site	Tulsa	Oklahoma
United States	511.75.01068 Boehringer Ingelheim Investigational Site	Waco	Texas
United States	511.75.01030 Boehringer Ingelheim Investigational Site	Washington	District of Columbia
United States	511.75.01002 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida
United States	511.75.01054 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sprout Pharmaceuticals, Inc

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.		28 weeks	Yes
Secondary	Changes from baseline on diary sexual distress question and on a small number of patient-completed questions/questionnaires.		28 weeks	Yes