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

Primary Purpose

Sexual Dysfunctions, Psychological

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
flibanserin
flibanserin
flibanserin
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 - 50 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. 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.

Sites / Locations

  • 511.70.01068 Boehringer Ingelheim Investigational Site
  • 511.70.01040 Boehringer Ingelheim Investigational Site
  • 511.70.01041 Boehringer Ingelheim Investigational Site
  • 511.70.01003 Boehringer Ingelheim Investigational Site
  • 511.70.01070 Boehringer Ingelheim Investigational Site
  • 511.70.01026 Boehringer Ingelheim Investigational Site
  • 511.70.01015 Boehringer Ingelheim Investigational Site
  • 511.70.01014 Boehringer Ingelheim Investigational Site
  • 511.70.01017 Boehringer Ingelheim Investigational Site
  • 511.70.01072 Boehringer Ingelheim Investigational Site
  • 511.70.01078 Boehringer Ingelheim Investigational Site
  • 511.70.01066 Boehringer Ingelheim Investigational Site
  • 511.70.01064 Boehringer Ingelheim Investigational Site
  • 511.70.01001 Boehringer Ingelheim Investigational Site
  • 511.70.01050 Boehringer Ingelheim Investigational Site
  • 511.70.01006 Boehringer Ingelheim Investigational Site
  • 511.70.01055 Boehringer Ingelheim Investigational Site
  • 511.70.01024 Boehringer Ingelheim Investigational Site
  • 511.70.01056 Boehringer Ingelheim Investigational Site
  • 511.70.01090 Boehringer Ingelheim Investigational Site
  • 511.70.01027 Boehringer Ingelheim Investigational Site
  • 511.70.01062 Boehringer Ingelheim Investigational Site
  • 511.70.01043 Boehringer Ingelheim Investigational Site
  • 511.70.01084 Boehringer Ingelheim Investigational Site
  • 511.70.01048 Boehringer Ingelheim Investigational Site
  • 511.70.01042 Boehringer Ingelheim Investigational Site
  • 511.70.01063 Boehringer Ingelheim Investigational Site
  • 511.70.01085 Boehringer Ingelheim Investigational Site
  • 511.70.01086 Boehringer Ingelheim Investigational Site
  • 511.70.01022 Boehringer Ingelheim Investigational Site
  • 511.70.01057 Boehringer Ingelheim Investigational Site
  • 511.70.01087 Boehringer Ingelheim Investigational Site
  • 511.70.01052 Boehringer Ingelheim Investigational Site
  • 511.70.01060 Boehringer Ingelheim Investigational Site
  • 511.70.01058 Boehringer Ingelheim Investigational Site
  • 511.70.01032 Boehringer Ingelheim Investigational Site
  • 511.70.01018 Boehringer Ingelheim Investigational Site
  • 511.70.01007 Boehringer Ingelheim Investigational Site
  • 511.70.01047 Boehringer Ingelheim Investigational Site
  • 511.70.01079 Boehringer Ingelheim Investigational Site
  • 511.70.01031 Boehringer Ingelheim Investigational Site
  • 511.70.01011 Boehringer Ingelheim Investigational Site
  • 511.70.01028 Boehringer Ingelheim Investigational Site
  • 511.70.01081 Boehringer Ingelheim Investigational Site
  • 511.70.01082 Boehringer Ingelheim Investigational Site
  • 511.70.01077 Boehringer Ingelheim Investigational Site
  • 511.70.01019 Boehringer Ingelheim Investigational Site
  • 511.70.01076 Boehringer Ingelheim Investigational Site
  • 511.70.01025 Boehringer Ingelheim Investigational Site
  • 511.70.01067 Boehringer Ingelheim Investigational Site
  • 511.70.01016 Boehringer Ingelheim Investigational Site
  • 511.70.01044 Boehringer Ingelheim Investigational Site
  • 511.70.01049 Boehringer Ingelheim Investigational Site
  • 511.70.01089 Boehringer Ingelheim Investigational Site
  • 511.70.01054 Boehringer Ingelheim Investigational Site
  • 511.70.01075 Boehringer Ingelheim Investigational Site
  • 511.70.01002 Boehringer Ingelheim Investigational Site
  • 511.70.01065 Boehringer Ingelheim Investigational Site
  • 511.70.01083 Boehringer Ingelheim Investigational Site
  • 511.70.01036 Boehringer Ingelheim Investigational Site
  • 511.70.01004 Boehringer Ingelheim Investigational Site
  • 511.70.01021 Boehringer Ingelheim Investigational Site
  • 511.70.01073 Boehringer Ingelheim Investigational Site
  • 511.70.01023 Boehringer Ingelheim Investigational Site
  • 511.70.01035 Boehringer Ingelheim Investigational Site
  • 511.70.01008 Boehringer Ingelheim Investigational Site
  • 511.70.01020 Boehringer Ingelheim Investigational Site
  • 511.70.01009 Boehringer Ingelheim Investigational Site
  • 511.70.01030 Boehringer Ingelheim Investigational Site
  • 511.70.01091 Boehringer Ingelheim Investigational Site
  • 511.70.01013 Boehringer Ingelheim Investigational Site
  • 511.70.01005 Boehringer Ingelheim Investigational Site
  • 511.70.01061 Boehringer Ingelheim Investigational Site
  • 511.70.01010 Boehringer Ingelheim Investigational Site
  • 511.70.01012 Boehringer Ingelheim Investigational Site
  • 511.70.01046 Boehringer Ingelheim Investigational Site
  • 511.70.01029 Boehringer Ingelheim Investigational Site
  • 511.70.01071 Boehringer Ingelheim Investigational Site
  • 511.70.01033 Boehringer Ingelheim Investigational Site
  • 511.70.01039 Boehringer Ingelheim Investigational Site
  • 511.70.01069 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 25 mg b.i.d

flibanserin 50mg qhs

flibanserin 50mg b.i.d.

placebo

Arm Description

25 mg twice daily for 24 weeks

50 mg taken once daily at bedtime for 24 weeks

50 mg twice daily for 24 weeks

twice daily for 24 weeks

Outcomes

Primary Outcome Measures

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.
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

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
NCT00360243
Brief Title
6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
Official Title
6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 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 meet 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
1385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flibanserin 25 mg b.i.d
Arm Type
Experimental
Arm Description
25 mg twice daily for 24 weeks
Arm Title
flibanserin 50mg qhs
Arm Type
Experimental
Arm Description
50 mg taken once daily at bedtime for 24 weeks
Arm Title
flibanserin 50mg b.i.d.
Arm Type
Experimental
Arm Description
50 mg twice daily for 24 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
twice daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
flibanserin
Intervention Description
Experimental: flibanserin 25 mg b.i.d
Intervention Type
Drug
Intervention Name(s)
flibanserin
Intervention Description
Experimental: flibanserin 50mg qhs
Intervention Type
Drug
Intervention Name(s)
flibanserin
Intervention Description
Experimental: flibanserin 50mg b.i.d.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
Description
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.
Time Frame
24 weeks
Title
Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.
Description
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
Time Frame
baseline to 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 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. 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.
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
511.70.01068 Boehringer Ingelheim Investigational Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
511.70.01040 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
511.70.01041 Boehringer Ingelheim Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
511.70.01003 Boehringer Ingelheim Investigational Site
City
Jonesboro
State/Province
Arkansas
Country
United States
Facility Name
511.70.01070 Boehringer Ingelheim Investigational Site
City
Carmichael
State/Province
California
Country
United States
Facility Name
511.70.01026 Boehringer Ingelheim Investigational Site
City
Redding
State/Province
California
Country
United States
Facility Name
511.70.01015 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.70.01014 Boehringer Ingelheim Investigational Site
City
Stanford
State/Province
California
Country
United States
Facility Name
511.70.01017 Boehringer Ingelheim Investigational Site
City
Tarzana
State/Province
California
Country
United States
Facility Name
511.70.01072 Boehringer Ingelheim Investigational Site
City
Torrance
State/Province
California
Country
United States
Facility Name
511.70.01078 Boehringer Ingelheim Investigational Site
City
Vista
State/Province
California
Country
United States
Facility Name
511.70.01066 Boehringer Ingelheim Investigational Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
511.70.01064 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
511.70.01001 Boehringer Ingelheim Investigational Site
City
Wheatridge
State/Province
Colorado
Country
United States
Facility Name
511.70.01050 Boehringer Ingelheim Investigational Site
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
511.70.01006 Boehringer Ingelheim Investigational Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
511.70.01055 Boehringer Ingelheim Investigational Site
City
New London
State/Province
Connecticut
Country
United States
Facility Name
511.70.01024 Boehringer Ingelheim Investigational Site
City
Aventura
State/Province
Florida
Country
United States
Facility Name
511.70.01056 Boehringer Ingelheim Investigational Site
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
511.70.01090 Boehringer Ingelheim Investigational Site
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
511.70.01027 Boehringer Ingelheim Investigational Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
511.70.01062 Boehringer Ingelheim Investigational Site
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
511.70.01043 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
511.70.01084 Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
511.70.01048 Boehringer Ingelheim Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
511.70.01042 Boehringer Ingelheim Investigational Site
City
Stuart
State/Province
Florida
Country
United States
Facility Name
511.70.01063 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
511.70.01085 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
511.70.01086 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
511.70.01022 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
511.70.01057 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
511.70.01087 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
511.70.01052 Boehringer Ingelheim Investigational Site
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
511.70.01060 Boehringer Ingelheim Investigational Site
City
Champaign
State/Province
Illinois
Country
United States
Facility Name
511.70.01058 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
511.70.01032 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
511.70.01018 Boehringer Ingelheim Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
511.70.01007 Boehringer Ingelheim Investigational Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
511.70.01047 Boehringer Ingelheim Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
511.70.01079 Boehringer Ingelheim Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
511.70.01031 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Maryland
Country
United States
Facility Name
511.70.01011 Boehringer Ingelheim Investigational Site
City
Haverhill
State/Province
Massachusetts
Country
United States
Facility Name
511.70.01028 Boehringer Ingelheim Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
511.70.01081 Boehringer Ingelheim Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
511.70.01082 Boehringer Ingelheim Investigational Site
City
Billings
State/Province
Montana
Country
United States
Facility Name
511.70.01077 Boehringer Ingelheim Investigational Site
City
Moorestown
State/Province
New Jersey
Country
United States
Facility Name
511.70.01019 Boehringer Ingelheim Investigational Site
City
Endwell
State/Province
New York
Country
United States
Facility Name
511.70.01076 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
511.70.01025 Boehringer Ingelheim Investigational Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
511.70.01067 Boehringer Ingelheim Investigational Site
City
Purchase
State/Province
New York
Country
United States
Facility Name
511.70.01016 Boehringer Ingelheim Investigational Site
City
Mount Airy
State/Province
North Carolina
Country
United States
Facility Name
511.70.01044 Boehringer Ingelheim Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
511.70.01049 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.70.01089 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.70.01054 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
511.70.01075 Boehringer Ingelheim Investigational Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
511.70.01002 Boehringer Ingelheim Investigational Site
City
Mayfield Heights
State/Province
Ohio
Country
United States
Facility Name
511.70.01065 Boehringer Ingelheim Investigational Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
511.70.01083 Boehringer Ingelheim Investigational Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
511.70.01036 Boehringer Ingelheim Investigational Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
511.70.01004 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
511.70.01021 Boehringer Ingelheim Investigational Site
City
West Reading
State/Province
Pennsylvania
Country
United States
Facility Name
511.70.01073 Boehringer Ingelheim Investigational Site
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
511.70.01023 Boehringer Ingelheim Investigational Site
City
Anderson
State/Province
South Carolina
Country
United States
Facility Name
511.70.01035 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
511.70.01008 Boehringer Ingelheim Investigational Site
City
Nasville
State/Province
Tennessee
Country
United States
Facility Name
511.70.01020 Boehringer Ingelheim Investigational Site
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
511.70.01009 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
511.70.01030 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
511.70.01091 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
511.70.01013 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.70.01005 Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
511.70.01061 Boehringer Ingelheim Investigational Site
City
Sandy
State/Province
Utah
Country
United States
Facility Name
511.70.01010 Boehringer Ingelheim Investigational Site
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
511.70.01012 Boehringer Ingelheim Investigational Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
511.70.01046 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
511.70.01029 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.70.01071 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.70.01033 Boehringer Ingelheim Investigational Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
511.70.01039 Boehringer Ingelheim Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
511.70.01069 Boehringer Ingelheim Investigational Site
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

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

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