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

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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunctions, Psychological
• Intervention / Treatment: Drug: placebo; Drug: flibanserin 50mg; Drug: flibanserin 100mg; Drug: flibanserin

• Study Type: Interventional
• Enrollment (Actual): 1584
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: flibanserin; flibanserin 25 mg b.i.d	Drug: flibanserin 50mg; flibanserin 50mg qhs/b.i.d.
EXPERIMENTAL: flibanserin 50mg; flibanserin 50mg qhs/b.i.d	Drug: flibanserin 100mg; flibanserin 50 mg b.i.d/100mg qhs
EXPERIMENTAL: flibanserin 100mg; flibanserin 50mg b.i.d./100mg qhs	Drug: placebo; placebo comparator
PLACEBO_COMPARATOR: placebo; placebo comparator	Drug: flibanserin; flibanserin 25 mg b.i.d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary.	For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms. For satisfying sexual events: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)	baseline to 28 weeks
Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question.	Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read "Indicate your most intense level of sexual desire in the last 24 hours / since your last visit." Potential responses included "no," "low," "moderate," or "strong" and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire: 0 = No desire; = Low desire; = Moderate desire; = Strong desire	baseline to 24 weeks

Collaborators and Investigators

• Sponsor: Sprout Pharmaceuticals, Inc

Publications and helpful links

General Publications

• Thorp J, Simon J, Dattani D, Taylor L, Kimura T, Garcia M Jr, Lesko L, Pyke R; DAISY trial investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. J Sex Med. 2012 Mar;9(3):793-804. doi: 10.1111/j.1743-6109.2011.02595.x. Epub 2012 Jan 12.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): March 1, 2008
• Study Completion (ACTUAL): March 1, 2008

Study Registration Dates

• First Submitted: August 3, 2006
• First Submitted That Met QC Criteria: August 3, 2006
• First Posted (ESTIMATE): August 4, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): June 27, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: 511.75