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

Primary Purpose

Sexual Dysfunctions, Psychological

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
flibanserin
flibanserin 50mg
flibanserin 100mg
placebo
Sponsored by
Sprout Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunctions, Psychological

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women who are 18 years of age and older. Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria. Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress. Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly. 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). At the Baseline Visit, patients must have complied with eDiary use adequately. 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. 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. 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. 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. 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. A score of 15 or higher on the FSDS-R at the screen Visit. Exclusion Criteria: Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening. 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. Patients with a history of drug dependence or abuse within the past one year. Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain. 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. 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. Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment. Patients who have entered the menopausal transition or menopause or have had a hysterectomy. Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs. Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit. Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit. 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. Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance. Patients who have started psychotherapy

Sites / Locations

  • 511.75.01015 Boehringer Ingelheim Investigational Site
  • 511.75.01028 Boehringer Ingelheim Investigational Site
  • 511.75.01051 Boehringer Ingelheim Investigational Site
  • 511.75.01063 Boehringer Ingelheim Investigational Site
  • 511.75.01017 Boehringer Ingelheim Investigational Site
  • 511.75.01014 Boehringer Ingelheim Investigational Site
  • 511.75.01042 Boehringer Ingelheim Investigational Site
  • 511.75.01022 Boehringer Ingelheim Investigational Site
  • 511.75.01005 Boehringer Ingelheim Investigational Site
  • 511.75.01053 Boehringer Ingelheim Investigational Site
  • 511.75.01045 Boehringer Ingelheim Investigational Site
  • 511.75.01065 Boehringer Ingelheim Investigational Site
  • 511.75.01003 Boehringer Ingelheim Investigational Site
  • 511.75.01030 Boehringer Ingelheim Investigational Site
  • 511.75.01066 Boehringer Ingelheim Investigational Site
  • 511.75.01040 Boehringer Ingelheim Investigational Site
  • 511.75.01001 Boehringer Ingelheim Investigational Site
  • 511.75.01062 Boehringer Ingelheim Investigational Site
  • 511.75.01032 Boehringer Ingelheim Investigational Site
  • 511.75.01047 Boehringer Ingelheim Investigational Site
  • 511.75.01073 Boehringer Ingelheim Investigational Site
  • 511.75.01035 Boehringer Ingelheim Investigational Site
  • 511.75.01010 Boehringer Ingelheim Investigational Site
  • 511.75.01041 Boehringer Ingelheim Investigational Site
  • 511.75.01033 Boehringer Ingelheim Investigational Site
  • 511.75.01002 Boehringer Ingelheim Investigational Site
  • 511.75.01006 Boehringer Ingelheim Investigational Site
  • 511.75.01023 Boehringer Ingelheim Investigational Site
  • 511.75.01031 Boehringer Ingelheim Investigational Site
  • 511.75.01050 Boehringer Ingelheim Investigational Site
  • 511.75.01043 Boehringer Ingelheim Investigational Site
  • 511.75.01025 Boehringer Ingelheim Investigational Site
  • 511.75.01024 Boehringer Ingelheim Investigational Site
  • 511.75.01009 Boehringer Ingelheim Investigational Site
  • 511.75.01060 Boehringer Ingelheim Investigational Site
  • 511.75.01004 Boehringer Ingelheim Investigational Site
  • 511.75.01037 Boehringer Ingelheim Investigational Site
  • 511.75.01054 Boehringer Ingelheim Investigational Site
  • 511.75.01069 Boehringer Ingelheim Investigational Site
  • 511.75.01012 Boehringer Ingelheim Investigational Site
  • 511.75.01071 Boehringer Ingelheim Investigational Site
  • 511.75.01038 Boehringer Ingelheim Investigational Site
  • 511.75.01048 Boehringer Ingelheim Investigational Site
  • 511.75.01061 Boehringer Ingelheim Investigational Site
  • 511.75.01020 Boehringer Ingelheim Investigational Site
  • 511.75.01052 Boehringer Ingelheim Investigational Site
  • 511.75.01059 Boehringer Ingelheim Investigational Site
  • 511.75.01021 Boehringer Ingelheim Investigational Site
  • 511.75.01018 Boehringer Ingelheim Investigational Site
  • 511.75.01067 Boehringer Ingelheim Investigational Site
  • 511.75.01070 Boehringer Ingelheim Investigational Site
  • 511.75.01064 Boehringer Ingelheim Investigational Site
  • 511.75.01049 Boehringer Ingelheim Investigational Site
  • 511.75.01013 Boehringer Ingelheim Investigational Site
  • 511.75.01027 Boehringer Ingelheim Investigational Site
  • 511.75.01044 Boehringer Ingelheim Investigational Site
  • 511.75.01011 Boehringer Ingelheim Investigational Site
  • 511.75.01055 Boehringer Ingelheim Investigational Site
  • 511.75.01068 Boehringer Ingelheim Investigational Site
  • 511.75.01007 Boehringer Ingelheim Investigational Site
  • 511.75.01057 Boehringer Ingelheim Investigational Site
  • 511.75.01046 Boehringer Ingelheim Investigational Site
  • 511.75.01019 Boehringer Ingelheim Investigational Site
  • 511.75.01036 Boehringer Ingelheim Investigational Site
  • 511.75.02008 Boehringer Ingelheim Investigational Site
  • 511.75.02002 Boehringer Ingelheim Investigational Site
  • 511.75.02004 Boehringer Ingelheim Investigational Site
  • 511.75.02005 Boehringer Ingelheim Investigational Site
  • 511.75.02010 Boehringer Ingelheim Investigational Site
  • 511.75.02011 Boehringer Ingelheim Investigational Site
  • 511.75.02001 Boehringer Ingelheim Investigational Site
  • 511.75.02007 Boehringer Ingelheim Investigational Site
  • 511.75.02009 Boehringer Ingelheim Investigational Site
  • 511.75.02013 Boehringer Ingelheim Investigational Site
  • 511.75.02003 Boehringer Ingelheim Investigational Site
  • 511.75.02012 Boehringer Ingelheim Investigational Site
  • 511.75.02014 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

flibanserin

flibanserin 50mg

flibanserin 100mg

placebo

Arm Description

flibanserin 25 mg b.i.d

flibanserin 50mg qhs/b.i.d

flibanserin 50mg b.i.d./100mg qhs

placebo comparator

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Full Information

First Posted
August 3, 2006
Last Updated
June 6, 2016
Sponsor
Sprout Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00360555
Brief Title
Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sprout Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunctions, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1584 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flibanserin
Arm Type
Experimental
Arm Description
flibanserin 25 mg b.i.d
Arm Title
flibanserin 50mg
Arm Type
Experimental
Arm Description
flibanserin 50mg qhs/b.i.d
Arm Title
flibanserin 100mg
Arm Type
Experimental
Arm Description
flibanserin 50mg b.i.d./100mg qhs
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo comparator
Intervention Type
Drug
Intervention Name(s)
flibanserin
Intervention Description
flibanserin 25 mg b.i.d
Intervention Type
Drug
Intervention Name(s)
flibanserin 50mg
Intervention Description
flibanserin 50mg qhs/b.i.d.
Intervention Type
Drug
Intervention Name(s)
flibanserin 100mg
Intervention Description
flibanserin 50 mg b.i.d/100mg qhs
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo comparator
Primary Outcome Measure Information:
Title
Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary.
Description
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)
Time Frame
baseline to 28 weeks
Title
Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question.
Description
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
Time Frame
baseline to 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who are 18 years of age and older. Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria. Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress. Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly. 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). At the Baseline Visit, patients must have complied with eDiary use adequately. 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. 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. 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. 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. 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. A score of 15 or higher on the FSDS-R at the screen Visit. Exclusion Criteria: Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening. 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. Patients with a history of drug dependence or abuse within the past one year. Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain. 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. 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. Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment. Patients who have entered the menopausal transition or menopause or have had a hysterectomy. Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs. Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit. Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit. 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. Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance. Patients who have started psychotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
511.75.01015 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
511.75.01028 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
511.75.01051 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
511.75.01063 Boehringer Ingelheim Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
511.75.01017 Boehringer Ingelheim Investigational Site
City
Berkeley
State/Province
California
Country
United States
Facility Name
511.75.01014 Boehringer Ingelheim Investigational Site
City
Encinitas
State/Province
California
Country
United States
Facility Name
511.75.01042 Boehringer Ingelheim Investigational Site
City
Fair Oaks
State/Province
California
Country
United States
Facility Name
511.75.01022 Boehringer Ingelheim Investigational Site
City
Irvine
State/Province
California
Country
United States
Facility Name
511.75.01005 Boehringer Ingelheim Investigational Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
511.75.01053 Boehringer Ingelheim Investigational Site
City
Sacremento
State/Province
California
Country
United States
Facility Name
511.75.01045 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.75.01065 Boehringer Ingelheim Investigational Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
511.75.01003 Boehringer Ingelheim Investigational Site
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
511.75.01030 Boehringer Ingelheim Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
511.75.01066 Boehringer Ingelheim Investigational Site
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
511.75.01040 Boehringer Ingelheim Investigational Site
City
Fort Meyers
State/Province
Florida
Country
United States
Facility Name
511.75.01001 Boehringer Ingelheim Investigational Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
511.75.01062 Boehringer Ingelheim Investigational Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
511.75.01032 Boehringer Ingelheim Investigational Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
511.75.01047 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
511.75.01073 Boehringer Ingelheim Investigational Site
City
Palm Bay
State/Province
Florida
Country
United States
Facility Name
511.75.01035 Boehringer Ingelheim Investigational Site
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
511.75.01010 Boehringer Ingelheim Investigational Site
City
South Miami
State/Province
Florida
Country
United States
Facility Name
511.75.01041 Boehringer Ingelheim Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
511.75.01033 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
511.75.01002 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
511.75.01006 Boehringer Ingelheim Investigational Site
City
Sandy Springs
State/Province
Georgia
Country
United States
Facility Name
511.75.01023 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
511.75.01031 Boehringer Ingelheim Investigational Site
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
511.75.01050 Boehringer Ingelheim Investigational Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
511.75.01043 Boehringer Ingelheim Investigational Site
City
Bingham Farms
State/Province
Michigan
Country
United States
Facility Name
511.75.01025 Boehringer Ingelheim Investigational Site
City
Chaska
State/Province
Minnesota
Country
United States
Facility Name
511.75.01024 Boehringer Ingelheim Investigational Site
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
511.75.01009 Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
511.75.01060 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
511.75.01004 Boehringer Ingelheim Investigational Site
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
511.75.01037 Boehringer Ingelheim Investigational Site
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
511.75.01054 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
511.75.01069 Boehringer Ingelheim Investigational Site
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
511.75.01012 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.75.01071 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.75.01038 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
511.75.01048 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
511.75.01061 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
511.75.01020 Boehringer Ingelheim Investigational Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
511.75.01052 Boehringer Ingelheim Investigational Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
511.75.01059 Boehringer Ingelheim Investigational Site
City
Medfod
State/Province
Oregon
Country
United States
Facility Name
511.75.01021 Boehringer Ingelheim Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
511.75.01018 Boehringer Ingelheim Investigational Site
City
Jenkintown
State/Province
Pennsylvania
Country
United States
Facility Name
511.75.01067 Boehringer Ingelheim Investigational Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
511.75.01070 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
511.75.01064 Boehringer Ingelheim Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
511.75.01049 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
511.75.01013 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
511.75.01027 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
511.75.01044 Boehringer Ingelheim Investigational Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
511.75.01011 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
511.75.01055 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.75.01068 Boehringer Ingelheim Investigational Site
City
Waco
State/Province
Texas
Country
United States
Facility Name
511.75.01007 Boehringer Ingelheim Investigational Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
511.75.01057 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
511.75.01046 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.75.01019 Boehringer Ingelheim Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
511.75.01036 Boehringer Ingelheim Investigational Site
City
Middleton
State/Province
Wisconsin
Country
United States
Facility Name
511.75.02008 Boehringer Ingelheim Investigational Site
City
Coquitlam
State/Province
British Columbia
Country
Canada
Facility Name
511.75.02002 Boehringer Ingelheim Investigational Site
City
North Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
511.75.02004 Boehringer Ingelheim Investigational Site
City
Woodstock
State/Province
New Brunswick
Country
Canada
Facility Name
511.75.02005 Boehringer Ingelheim Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
511.75.02010 Boehringer Ingelheim Investigational Site
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
511.75.02011 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
511.75.02001 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
511.75.02007 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
511.75.02009 Boehringer Ingelheim Investigational Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
511.75.02013 Boehringer Ingelheim Investigational Site
City
Trois-Rivières
State/Province
Quebec
Country
Canada
Facility Name
511.75.02003 Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
511.75.02012 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada
Facility Name
511.75.02014 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22239862
Citation
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.
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Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

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