6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA

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 meet 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; Drug: flibanserin; Drug: flibanserin

• Study Type: Interventional
• Enrollment (Actual): 1385
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States
      • 511.70.01068 Boehringer Ingelheim Investigational Site
    • Mobile, Alabama, United States
      • 511.70.01040 Boehringer Ingelheim Investigational Site
  • Arizona
    • Tucson, Arizona, United States
      • 511.70.01041 Boehringer Ingelheim Investigational Site
  • Arkansas
    • Jonesboro, Arkansas, United States
      • 511.70.01003 Boehringer Ingelheim Investigational Site
  • California
    • Carmichael, California, United States
      • 511.70.01070 Boehringer Ingelheim Investigational Site
    • Redding, California, United States
      • 511.70.01026 Boehringer Ingelheim Investigational Site
    • San Diego, California, United States
      • 511.70.01015 Boehringer Ingelheim Investigational Site
    • Stanford, California, United States
      • 511.70.01014 Boehringer Ingelheim Investigational Site
    • Tarzana, California, United States
      • 511.70.01017 Boehringer Ingelheim Investigational Site
    • Torrance, California, United States
      • 511.70.01072 Boehringer Ingelheim Investigational Site
    • Vista, California, United States
      • 511.70.01078 Boehringer Ingelheim Investigational Site
    • Walnut Creek, California, United States
      • 511.70.01066 Boehringer Ingelheim Investigational Site
  • Colorado
    • Denver, Colorado, United States
      • 511.70.01064 Boehringer Ingelheim Investigational Site
    • Wheatridge, Colorado, United States
      • 511.70.01001 Boehringer Ingelheim Investigational Site
  • Connecticut
    • Farmington, Connecticut, United States
      • 511.70.01050 Boehringer Ingelheim Investigational Site
    • Hartford, Connecticut, United States
      • 511.70.01006 Boehringer Ingelheim Investigational Site
    • New London, Connecticut, United States
      • 511.70.01055 Boehringer Ingelheim Investigational Site
  • Florida
    • Aventura, Florida, United States
      • 511.70.01024 Boehringer Ingelheim Investigational Site
    • Daytona Beach, Florida, United States
      • 511.70.01056 Boehringer Ingelheim Investigational Site
    • Ft. Lauderdale, Florida, United States
      • 511.70.01090 Boehringer Ingelheim Investigational Site
    • Gainesville, Florida, United States
      • 511.70.01027 Boehringer Ingelheim Investigational Site
    • New Port Richey, Florida, United States
      • 511.70.01062 Boehringer Ingelheim Investigational Site
    • Orlando, Florida, United States
      • 511.70.01043 Boehringer Ingelheim Investigational Site
    • Pembroke Pines, Florida, United States
      • 511.70.01084 Boehringer Ingelheim Investigational Site
    • St. Petersburg, Florida, United States
      • 511.70.01048 Boehringer Ingelheim Investigational Site
    • Stuart, Florida, United States
      • 511.70.01042 Boehringer Ingelheim Investigational Site
    • Tampa, Florida, United States
      • 511.70.01063 Boehringer Ingelheim Investigational Site
    • Tampa, Florida, United States
      • 511.70.01085 Boehringer Ingelheim Investigational Site
    • West Palm Beach, Florida, United States
      • 511.70.01086 Boehringer Ingelheim Investigational Site
  • Georgia
    • Atlanta, Georgia, United States
      • 511.70.01022 Boehringer Ingelheim Investigational Site
    • Atlanta, Georgia, United States
      • 511.70.01057 Boehringer Ingelheim Investigational Site
    • Atlanta, Georgia, United States
      • 511.70.01087 Boehringer Ingelheim Investigational Site
    • Roswell, Georgia, United States
      • 511.70.01052 Boehringer Ingelheim Investigational Site
  • Illinois
    • Champaign, Illinois, United States
      • 511.70.01060 Boehringer Ingelheim Investigational Site
    • Chicago, Illinois, United States
      • 511.70.01058 Boehringer Ingelheim Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States
      • 511.70.01032 Boehringer Ingelheim Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States
      • 511.70.01018 Boehringer Ingelheim Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States
      • 511.70.01007 Boehringer Ingelheim Investigational Site
    • New Orleans, Louisiana, United States
      • 511.70.01047 Boehringer Ingelheim Investigational Site
    • New Orleans, Louisiana, United States
      • 511.70.01079 Boehringer Ingelheim Investigational Site
  • Maryland
    • St. Louis, Maryland, United States
      • 511.70.01031 Boehringer Ingelheim Investigational Site
  • Massachusetts
    • Haverhill, Massachusetts, United States
      • 511.70.01011 Boehringer Ingelheim Investigational Site
  • Michigan
    • Detroit, Michigan, United States
      • 511.70.01028 Boehringer Ingelheim Investigational Site
    • Detroit, Michigan, United States
      • 511.70.01081 Boehringer Ingelheim Investigational Site
  • Montana
    • Billings, Montana, United States
      • 511.70.01082 Boehringer Ingelheim Investigational Site
  • New Jersey
    • Moorestown, New Jersey, United States
      • 511.70.01077 Boehringer Ingelheim Investigational Site
  • New York
    • Endwell, New York, United States
      • 511.70.01019 Boehringer Ingelheim Investigational Site
    • New York, New York, United States
      • 511.70.01076 Boehringer Ingelheim Investigational Site
    • Poughkeepsie, New York, United States
      • 511.70.01025 Boehringer Ingelheim Investigational Site
    • Purchase, New York, United States
      • 511.70.01067 Boehringer Ingelheim Investigational Site
  • North Carolina
    • Mount Airy, North Carolina, United States
      • 511.70.01016 Boehringer Ingelheim Investigational Site
    • Raleigh, North Carolina, United States
      • 511.70.01044 Boehringer Ingelheim Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States
      • 511.70.01049 Boehringer Ingelheim Investigational Site
    • Cincinnati, Ohio, United States
      • 511.70.01089 Boehringer Ingelheim Investigational Site
    • Columbus, Ohio, United States
      • 511.70.01054 Boehringer Ingelheim Investigational Site
    • Dayton, Ohio, United States
      • 511.70.01075 Boehringer Ingelheim Investigational Site
    • Mayfield Heights, Ohio, United States
      • 511.70.01002 Boehringer Ingelheim Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States
      • 511.70.01065 Boehringer Ingelheim Investigational Site
    • Tulsa, Oklahoma, United States
      • 511.70.01083 Boehringer Ingelheim Investigational Site
  • Oregon
    • Medford, Oregon, United States
      • 511.70.01036 Boehringer Ingelheim Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • 511.70.01004 Boehringer Ingelheim Investigational Site
    • West Reading, Pennsylvania, United States
      • 511.70.01021 Boehringer Ingelheim Investigational Site
  • Rhode Island
    • Warwick, Rhode Island, United States
      • 511.70.01073 Boehringer Ingelheim Investigational Site
  • South Carolina
    • Anderson, South Carolina, United States
      • 511.70.01023 Boehringer Ingelheim Investigational Site
    • Charleston, South Carolina, United States
      • 511.70.01035 Boehringer Ingelheim Investigational Site
  • Tennessee
    • Nasville, Tennessee, United States
      • 511.70.01008 Boehringer Ingelheim Investigational Site
  • Texas
    • Corpus Christi, Texas, United States
      • 511.70.01020 Boehringer Ingelheim Investigational Site
    • Dallas, Texas, United States
      • 511.70.01009 Boehringer Ingelheim Investigational Site
    • Houston, Texas, United States
      • 511.70.01030 Boehringer Ingelheim Investigational Site
    • Houston, Texas, United States
      • 511.70.01091 Boehringer Ingelheim Investigational Site
    • San Antonio, Texas, United States
      • 511.70.01013 Boehringer Ingelheim Investigational Site
  • Utah
    • Salt Lake City, Utah, United States
      • 511.70.01005 Boehringer Ingelheim Investigational Site
    • Sandy, Utah, United States
      • 511.70.01061 Boehringer Ingelheim Investigational Site
  • Vermont
    • Burlington, Vermont, United States
      • 511.70.01010 Boehringer Ingelheim Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States
      • 511.70.01012 Boehringer Ingelheim Investigational Site
    • Norfolk, Virginia, United States
      • 511.70.01046 Boehringer Ingelheim Investigational Site
    • Richmond, Virginia, United States
      • 511.70.01029 Boehringer Ingelheim Investigational Site
    • Richmond, Virginia, United States
      • 511.70.01071 Boehringer Ingelheim Investigational Site
  • Washington
    • Bellevue, Washington, United States
      • 511.70.01033 Boehringer Ingelheim Investigational Site
    • Tacoma, Washington, United States
      • 511.70.01039 Boehringer Ingelheim Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • 511.70.01069 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: flibanserin 25 mg b.i.d; 25 mg twice daily for 24 weeks	Drug: flibanserin; Experimental: flibanserin 25 mg b.i.d; Drug: flibanserin; Experimental: flibanserin 50mg qhs; Drug: flibanserin; Experimental: flibanserin 50mg b.i.d.
Experimental: flibanserin 50mg qhs; 50 mg taken once daily at bedtime for 24 weeks	Drug: flibanserin; Experimental: flibanserin 25 mg b.i.d; Drug: flibanserin; Experimental: flibanserin 50mg qhs; Drug: flibanserin; Experimental: flibanserin 50mg b.i.d.
Experimental: flibanserin 50mg b.i.d.; 50 mg twice daily for 24 weeks	Drug: flibanserin; Experimental: flibanserin 25 mg b.i.d; Drug: flibanserin; Experimental: flibanserin 50mg qhs; Drug: flibanserin; Experimental: flibanserin 50mg b.i.d.
Placebo Comparator: placebo; twice daily for 24 weeks	Drug: placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.	A small personal handheld electronic device (eDiary) was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.	24 weeks
Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.	Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total 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

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 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: 511.70