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A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

Primary Purpose

Sexual Dysfunctions, Psychological

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
flibanserin
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 - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  1. Women with primary diagnosis of Hypoactive Sexual Desire Disorder (HSDD) who completed a prior trial of flibanserin. Such completion requires compliance with trial medication and the trial visit schedule including any post-treatment visits required in that clinical trial. Early discontinuation for any reason disqualifies the patient from entry into this trial. Patients must enroll in this study within 7 days after completing the final visit of the parent trial.
  2. The premenopausal patient must use a medically acceptable method of contraception for at least two months before baseline and continue to use medically acceptable method of contraception during the trial.
  3. Postmenopausal patients must be a naturally postmenopausal woman of any age with at least one ovary. Natural menopause is defined as greater than 12 months of spontaneous amenorrhea.
  4. In the investigator's opinion, patients must be willing to adhere to trial requirements as well as to be able to perform them.
  5. 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 sexual functioning with study staff.

Exclusion criteria:

  1. Patients with history of Major Depressive Disorder (MDD) within six months prior to the Screen Visit, or a score of greater than or equal to 14 on the Beck Depression Inventory II (BDI-II), or a history of suicidal behavior or suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS®). If a psychiatrist or psychologist, using clinical judgment, believes a patient who scored between 14 and 19 on the BDI®-II is not depressed, the patient may be entered into the trial. NOTE: If a patient reports positive response to BDI®-II Question 9 and/or a Yes response to either C-SSRS® Suicide Ideation section Question 1 and/or 2 and/or any question in the Suicide Behavior section, please refer to Section 5.2.5 for immediate actions required.
  2. At the Screen Visit, serum alanine aminotransferase, serum aspartate aminotransferase, alkaline phosphatase, or total bilirubin greater than or equal to three times upper limit of normal; blood urea nitrogen greater than or equal to 30 mg/deciliter (dL), plasma creatinine greater than or equal to 2 mg/dL, hemoglobin <9.5 grams/dL, leukopenia (<2.5 x 103/microliter [µL]), neutropenia (<1.5 x 103/µL), lymphopenia (<0.8 x 103/µL), thrombocytopenia (<100 x 103/µL) or thrombocytosis (>500 x 103/µL); or random glucose > upper limit of normal.
  3. Patients with newly developed, self-reported symptoms after the End of Treatment parent trial visit and at this trial Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection / vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
  4. Patients with history of any cancer within the last ten years, other than non-invasive, previously resected basal cell carcinoma of the skin.
  5. Patients whose sexual function was affected by hysterectomy, oophorectomy, or any other pelvic or vaginal surgery.
  6. Patients who are pregnant (by urine pregnancy test at the Screen Visit) or have been pregnant within the month prior to the Screen Visit or who are breast-feeding or have breast-fed within the last six months prior to the Baseline Visit.
  7. Patients receiving medication excluded in their prior safety and efficacy trial of flibanserin causing sexual dysfunction or safety-relevant interactions (i.e., antidepressants, anxiolytics, antipsychotics, anticonvulsants, anticoagulants).
  8. Patients with clinically relevant conditions which might interfere with their ability to participate in the trial.
  9. Participation in a trial of an investigational medication other than flibanserin within one month prior to the Screen Visit.

Sites / Locations

  • 511.133.01074 Boehringer Ingelheim Investigational Site
  • 511.133.01141 Boehringer Ingelheim Investigational Site
  • 511.133.01046 Boehringer Ingelheim Investigational Site
  • 511.133.01042 Boehringer Ingelheim Investigational Site
  • 511.133.01025 Boehringer Ingelheim Investigational Site
  • 511.133.01073 Boehringer Ingelheim Investigational Site
  • 511.133.01127 Boehringer Ingelheim Investigational Site
  • 511.133.01030 Boehringer Ingelheim Investigational Site
  • 511.133.01028 Boehringer Ingelheim Investigational Site
  • 511.133.01037 Boehringer Ingelheim Investigational Site
  • 511.133.01136 Boehringer Ingelheim Investigational Site
  • 511.133.01128 Boehringer Ingelheim Investigational Site
  • 511.133.01115 Boehringer Ingelheim Investigational Site
  • 511.133.01022 Boehringer Ingelheim Investigational Site
  • 511.133.01035 Boehringer Ingelheim Investigational Site
  • 511.133.01052 Boehringer Ingelheim Investigational Site
  • 511.133.01099 Boehringer Ingelheim Investigational Site
  • 511.133.01016 Boehringer Ingelheim Investigational Site
  • 511.133.01021 Boehringer Ingelheim Investigational Site
  • 511.133.01051 Boehringer Ingelheim Investigational Site
  • 511.133.01071 Boehringer Ingelheim Investigational Site
  • 511.133.01053 Boehringer Ingelheim Investigational Site
  • 511.133.01015 Boehringer Ingelheim Investigational Site
  • 511.133.01139 Boehringer Ingelheim Investigational Site
  • 511.133.01064 Boehringer Ingelheim Investigational Site
  • 511.133.01062 Boehringer Ingelheim Investigational Site
  • 511.133.01003 Boehringer Ingelheim Investigational Site
  • 511.133.01056 Boehringer Ingelheim Investigational Site
  • 511.133.01132 Boehringer Ingelheim Investigational Site
  • 511.133.01065 Boehringer Ingelheim Investigational Site
  • 511.133.01020 Boehringer Ingelheim Investigational Site
  • 511.133.01024 Boehringer Ingelheim Investigational Site
  • 511.133.01043 Boehringer Ingelheim Investigational Site
  • 511.133.01070 Boehringer Ingelheim Investigational Site
  • 511.133.01019 Boehringer Ingelheim Investigational Site
  • 511.133.01061 Boehringer Ingelheim Investigational Site
  • 511.133.01066 Boehringer Ingelheim Investigational Site
  • 511.133.01001 Boehringer Ingelheim Investigational Site
  • 511.133.01002 Boehringer Ingelheim Investigational Site
  • 511.133.01009 Boehringer Ingelheim Investigational Site
  • 511.133.01023 Boehringer Ingelheim Investigational Site
  • 511.133.01082 Boehringer Ingelheim Investigational Site
  • 511.133.01008 Boehringer Ingelheim Investigational Site
  • 511.133.01044 Boehringer Ingelheim Investigational Site
  • 511.133.01034 Boehringer Ingelheim Investigational Site
  • 511.133.01100 Boehringer Ingelheim Investigational Site
  • 511.133.01067 Boehringer Ingelheim Investigational Site
  • 511.133.01013 Boehringer Ingelheim Investigational Site
  • 511.133.01031 Boehringer Ingelheim Investigational Site
  • 511.133.01006 Boehringer Ingelheim Investigational Site
  • 511.133.01014 Boehringer Ingelheim Investigational Site
  • 511.133.01060 Boehringer Ingelheim Investigational Site
  • 511.133.01057 Boehringer Ingelheim Investigational Site
  • 511.133.01039 Boehringer Ingelheim Investigational Site
  • 511.133.01017 Boehringer Ingelheim Investigational Site
  • 511.133.01135 Boehringer Ingelheim Investigational Site
  • 511.133.01047 Boehringer Ingelheim Investigational Site
  • 511.133.01138 Boehringer Ingelheim Investigational Site
  • 511.133.01027 Boehringer Ingelheim Investigational Site
  • 511.133.01119 Boehringer Ingelheim Investigational Site
  • 511.133.01033 Boehringer Ingelheim Investigational Site
  • 511.133.01004 Boehringer Ingelheim Investigational Site
  • 511.133.01050 Boehringer Ingelheim Investigational Site
  • 511.133.01059 Boehringer Ingelheim Investigational Site
  • 511.133.01058 Boehringer Ingelheim Investigational Site
  • 511.133.01105 Boehringer Ingelheim Investigational Site
  • 511.133.01072 Boehringer Ingelheim Investigational Site
  • 511.133.01007 Boehringer Ingelheim Investigational Site
  • 511.133.01055 Boehringer Ingelheim Investigational Site
  • 511.133.01068 Boehringer Ingelheim Investigational Site
  • 511.133.01084 Boehringer Ingelheim Investigational Site
  • 511.133.01063 Boehringer Ingelheim Investigational Site
  • 511.133.01010 Boehringer Ingelheim Investigational Site
  • 511.133.01036 Boehringer Ingelheim Investigational Site
  • 511.133.01018 Boehringer Ingelheim Investigational Site
  • 511.133.01032 Boehringer Ingelheim Investigational Site
  • 511.133.01011 Boehringer Ingelheim Investigational Site
  • 511.133.01012 Boehringer Ingelheim Investigational Site
  • 511.133.01026 Boehringer Ingelheim Investigational Site
  • 511.133.01005 Boehringer Ingelheim Investigational Site
  • 511.133.01069 Boehringer Ingelheim Investigational Site
  • 511.133.01040 Boehringer Ingelheim Investigational Site
  • 511.133.01029 Boehringer Ingelheim Investigational Site
  • 511.133.01075 Boehringer Ingelheim Investigational Site
  • 511.133.01049 Boehringer Ingelheim Investigational Site
  • 511.133.01054 Boehringer Ingelheim Investigational Site
  • 511.133.01045 Boehringer Ingelheim Investigational Site
  • 511.133.01038 Boehringer Ingelheim Investigational Site
  • 511.133.02004 Boehringer Ingelheim Investigational Site
  • 511.133.02014 Boehringer Ingelheim Investigational Site
  • 511.133.02006 Boehringer Ingelheim Investigational Site
  • 511.133.02005 Boehringer Ingelheim Investigational Site
  • 511.133.02016 Boehringer Ingelheim Investigational Site
  • 511.133.02003 Boehringer Ingelheim Investigational Site
  • 511.133.02002 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

flibanserin 100mg

Arm Description

flibanserin 100mg po qd

Outcomes

Primary Outcome Measures

The Frequency of Adverse Events

Secondary Outcome Measures

Full Information

First Posted
April 13, 2010
Last Updated
April 11, 2014
Sponsor
Sprout Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01103362
Brief Title
A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder
Official Title
Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
administrative reasons
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (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
To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
596 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flibanserin 100mg
Arm Type
Experimental
Arm Description
flibanserin 100mg po qd
Intervention Type
Drug
Intervention Name(s)
flibanserin
Intervention Description
all patients will receive open-label flibanserin 100mg
Primary Outcome Measure Information:
Title
The Frequency of Adverse Events
Time Frame
A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Women with primary diagnosis of Hypoactive Sexual Desire Disorder (HSDD) who completed a prior trial of flibanserin. Such completion requires compliance with trial medication and the trial visit schedule including any post-treatment visits required in that clinical trial. Early discontinuation for any reason disqualifies the patient from entry into this trial. Patients must enroll in this study within 7 days after completing the final visit of the parent trial. The premenopausal patient must use a medically acceptable method of contraception for at least two months before baseline and continue to use medically acceptable method of contraception during the trial. Postmenopausal patients must be a naturally postmenopausal woman of any age with at least one ovary. Natural menopause is defined as greater than 12 months of spontaneous amenorrhea. In the investigator's opinion, patients must be willing to adhere to trial requirements 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 sexual functioning with study staff. Exclusion criteria: Patients with history of Major Depressive Disorder (MDD) within six months prior to the Screen Visit, or a score of greater than or equal to 14 on the Beck Depression Inventory II (BDI-II), or a history of suicidal behavior or suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS®). If a psychiatrist or psychologist, using clinical judgment, believes a patient who scored between 14 and 19 on the BDI®-II is not depressed, the patient may be entered into the trial. NOTE: If a patient reports positive response to BDI®-II Question 9 and/or a Yes response to either C-SSRS® Suicide Ideation section Question 1 and/or 2 and/or any question in the Suicide Behavior section, please refer to Section 5.2.5 for immediate actions required. At the Screen Visit, serum alanine aminotransferase, serum aspartate aminotransferase, alkaline phosphatase, or total bilirubin greater than or equal to three times upper limit of normal; blood urea nitrogen greater than or equal to 30 mg/deciliter (dL), plasma creatinine greater than or equal to 2 mg/dL, hemoglobin <9.5 grams/dL, leukopenia (<2.5 x 103/microliter [µL]), neutropenia (<1.5 x 103/µL), lymphopenia (<0.8 x 103/µL), thrombocytopenia (<100 x 103/µL) or thrombocytosis (>500 x 103/µL); or random glucose > upper limit of normal. Patients with newly developed, self-reported symptoms after the End of Treatment parent trial visit and at this trial Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection / vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy. Patients with history of any cancer within the last ten years, other than non-invasive, previously resected basal cell carcinoma of the skin. Patients whose sexual function was affected by hysterectomy, oophorectomy, or any other pelvic or vaginal surgery. Patients who are pregnant (by urine pregnancy test at the Screen Visit) or have been pregnant within the month prior to the Screen Visit or who are breast-feeding or have breast-fed within the last six months prior to the Baseline Visit. Patients receiving medication excluded in their prior safety and efficacy trial of flibanserin causing sexual dysfunction or safety-relevant interactions (i.e., antidepressants, anxiolytics, antipsychotics, anticonvulsants, anticoagulants). Patients with clinically relevant conditions which might interfere with their ability to participate in the trial. Participation in a trial of an investigational medication other than flibanserin within one month prior to the Screen Visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sprout Pharmaceuticals
Organizational Affiliation
Sprout Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
511.133.01074 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
511.133.01141 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
511.133.01046 Boehringer Ingelheim Investigational Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
511.133.01042 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
511.133.01025 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
511.133.01073 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
511.133.01127 Boehringer Ingelheim Investigational Site
City
Tuscon
State/Province
Arizona
Country
United States
Facility Name
511.133.01030 Boehringer Ingelheim Investigational Site
City
Encinitas
State/Province
California
Country
United States
Facility Name
511.133.01028 Boehringer Ingelheim Investigational Site
City
Fair Oaks
State/Province
California
Country
United States
Facility Name
511.133.01037 Boehringer Ingelheim Investigational Site
City
Irvine
State/Province
California
Country
United States
Facility Name
511.133.01136 Boehringer Ingelheim Investigational Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
511.133.01128 Boehringer Ingelheim Investigational Site
City
Newport Beach
State/Province
California
Country
United States
Facility Name
511.133.01115 Boehringer Ingelheim Investigational Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
511.133.01022 Boehringer Ingelheim Investigational Site
City
Sacremento
State/Province
California
Country
United States
Facility Name
511.133.01035 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.133.01052 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.133.01099 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.133.01016 Boehringer Ingelheim Investigational Site
City
Tarzana
State/Province
California
Country
United States
Facility Name
511.133.01021 Boehringer Ingelheim Investigational Site
City
Vista
State/Province
California
Country
United States
Facility Name
511.133.01051 Boehringer Ingelheim Investigational Site
City
Westlake Village
State/Province
California
Country
United States
Facility Name
511.133.01071 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
511.133.01053 Boehringer Ingelheim Investigational Site
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
511.133.01015 Boehringer Ingelheim Investigational Site
City
Groton
State/Province
Connecticut
Country
United States
Facility Name
511.133.01139 Boehringer Ingelheim Investigational Site
City
New London
State/Province
Connecticut
Country
United States
Facility Name
511.133.01064 Boehringer Ingelheim Investigational Site
City
Newark
State/Province
Delaware
Country
United States
Facility Name
511.133.01062 Boehringer Ingelheim Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
511.133.01003 Boehringer Ingelheim Investigational Site
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
511.133.01056 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
511.133.01132 Boehringer Ingelheim Investigational Site
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
511.133.01065 Boehringer Ingelheim Investigational Site
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
511.133.01020 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
511.133.01024 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
511.133.01043 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
511.133.01070 Boehringer Ingelheim Investigational Site
City
Palm Harbor
State/Province
Florida
Country
United States
Facility Name
511.133.01019 Boehringer Ingelheim Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
511.133.01061 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
511.133.01066 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
511.133.01001 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
511.133.01002 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
511.133.01009 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
511.133.01023 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
511.133.01082 Boehringer Ingelheim Investigational Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
511.133.01008 Boehringer Ingelheim Investigational Site
City
Sandy Springs
State/Province
Georgia
Country
United States
Facility Name
511.133.01044 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
511.133.01034 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
511.133.01100 Boehringer Ingelheim Investigational Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
511.133.01067 Boehringer Ingelheim Investigational Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
511.133.01013 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
511.133.01031 Boehringer Ingelheim Investigational Site
City
Bingham Farms
State/Province
Michigan
Country
United States
Facility Name
511.133.01006 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
511.133.01014 Boehringer Ingelheim Investigational Site
City
Billings
State/Province
Montana
Country
United States
Facility Name
511.133.01060 Boehringer Ingelheim Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
511.133.01057 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
511.133.01039 Boehringer Ingelheim Investigational Site
City
Moorestown
State/Province
New Jersey
Country
United States
Facility Name
511.133.01017 Boehringer Ingelheim Investigational Site
City
Endwell
State/Province
New York
Country
United States
Facility Name
511.133.01135 Boehringer Ingelheim Investigational Site
City
Cary
State/Province
North Carolina
Country
United States
Facility Name
511.133.01047 Boehringer Ingelheim Investigational Site
City
New Bern
State/Province
North Carolina
Country
United States
Facility Name
511.133.01138 Boehringer Ingelheim Investigational Site
City
Winston Salem
State/Province
North Carolina
Country
United States
Facility Name
511.133.01027 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
511.133.01119 Boehringer Ingelheim Investigational Site
City
Fargo
State/Province
North Dakota
Country
United States
Facility Name
511.133.01033 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.133.01004 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
511.133.01050 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
511.133.01059 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
511.133.01058 Boehringer Ingelheim Investigational Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
511.133.01105 Boehringer Ingelheim Investigational Site
City
Englewood
State/Province
Ohio
Country
United States
Facility Name
511.133.01072 Boehringer Ingelheim Investigational Site
City
Edmond
State/Province
Oklahoma
Country
United States
Facility Name
511.133.01007 Boehringer Ingelheim Investigational Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
511.133.01055 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
511.133.01068 Boehringer Ingelheim Investigational Site
City
Mt Pleasant
State/Province
South Carolina
Country
United States
Facility Name
511.133.01084 Boehringer Ingelheim Investigational Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
511.133.01063 Boehringer Ingelheim Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
511.133.01010 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
511.133.01036 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
511.133.01018 Boehringer Ingelheim Investigational Site
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
511.133.01032 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
511.133.01011 Boehringer Ingelheim Investigational Site
City
Katy
State/Province
Texas
Country
United States
Facility Name
511.133.01012 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.133.01026 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.133.01005 Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
511.133.01069 Boehringer Ingelheim Investigational Site
City
Sandy
State/Province
Utah
Country
United States
Facility Name
511.133.01040 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
511.133.01029 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.133.01075 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.133.01049 Boehringer Ingelheim Investigational Site
City
Virgnia Beach
State/Province
Virginia
Country
United States
Facility Name
511.133.01054 Boehringer Ingelheim Investigational Site
City
Renton
State/Province
Washington
Country
United States
Facility Name
511.133.01045 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
511.133.01038 Boehringer Ingelheim Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
511.133.02004 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
511.133.02014 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
511.133.02006 Boehringer Ingelheim Investigational Site
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
511.133.02005 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
511.133.02016 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
511.133.02003 Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
511.133.02002 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29502984
Citation
Simon JA, Derogatis L, Portman D, Brown L, Yuan J, Kissling R. Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study. J Sex Med. 2018 Mar;15(3):387-395. doi: 10.1016/j.jsxm.2017.12.016.
Results Reference
derived

Learn more about this trial

A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

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