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A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

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 - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
  2. Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study.
  3. Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
  4. Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff.

Exclusion Criteria:

  1. A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt.
  2. Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
  3. Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
  4. Patients who are pregnant or have been pregnant within 1 month prior to study start.
  5. Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD.
  6. Clinically significant ECG or lab abnormalities at study start.
  7. Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.

Sites / Locations

  • 511.84.01079 Boehringer Ingelheim Investigational Site
  • 511.84.01193 Boehringer Ingelheim Investigational Site
  • 511.84.01188 Boehringer Ingelheim Investigational Site
  • 511.84.01110 Boehringer Ingelheim Investigational Site
  • 511.84.01142 Boehringer Ingelheim Investigational Site
  • 511.84.01157 Boehringer Ingelheim Investigational Site
  • 511.84.01162 Boehringer Ingelheim Investigational Site
  • 511.84.01070 Boehringer Ingelheim Investigational Site
  • 511.84.01191 Boehringer Ingelheim Investigational Site
  • 511.84.01115 Boehringer Ingelheim Investigational Site
  • 511.84.01013 Boehringer Ingelheim Investigational Site
  • 511.84.01087 Boehringer Ingelheim Investigational Site
  • 511.84.01077 Boehringer Ingelheim Investigational Site
  • 511.84.01074 Boehringer Ingelheim Investigational Site
  • 511.84.01104 Boehringer Ingelheim Investigational Site
  • 511.84.01037 Boehringer Ingelheim Investigational Site
  • 511.84.01056 Boehringer Ingelheim Investigational Site
  • 511.84.01195 Boehringer Ingelheim Investigational Site
  • 511.84.01043 Boehringer Ingelheim Investigational Site
  • 511.84.01047 Boehringer Ingelheim Investigational Site
  • 511.84.01096 Boehringer Ingelheim Investigational Site
  • 511.84.01040 Boehringer Ingelheim Investigational Site
  • 511.84.01048 Boehringer Ingelheim Investigational Site
  • 511.84.01017 Boehringer Ingelheim Investigational Site
  • 511.84.01173 Boehringer Ingelheim Investigational Site
  • 511.84.01029 Boehringer Ingelheim Investigational Site
  • 511.84.01137 Boehringer Ingelheim Investigational Site
  • 511.84.01090 Boehringer Ingelheim Investigational Site
  • 511.84.01164 Boehringer Ingelheim Investigational Site
  • 511.84.01184 Boehringer Ingelheim Investigational Site
  • 511.84.01004 Boehringer Ingelheim Investigational Site
  • 511.84.01006 Boehringer Ingelheim Investigational Site
  • 511.84.01138 Boehringer Ingelheim Investigational Site
  • 511.84.01044 Boehringer Ingelheim Investigational Site
  • 511.84.01016 Boehringer Ingelheim Investigational Site
  • 511.84.01108 Boehringer Ingelheim Investigational Site
  • 511.84.01168 Boehringer Ingelheim Investigational Site
  • 511.84.01166 Boehringer Ingelheim Investigational Site
  • 511.84.01160 Boehringer Ingelheim Investigational Site
  • 511.84.01065 Boehringer Ingelheim Investigational Site
  • 511.84.01005 Boehringer Ingelheim Investigational Site
  • 511.84.01146 Boehringer Ingelheim Investigational Site
  • 511.84.01144 Boehringer Ingelheim Investigational Site
  • 511.84.01169 Boehringer Ingelheim Investigational Site
  • 511.84.01085 Boehringer Ingelheim Investigational Site
  • 511.84.01194 Boehringer Ingelheim Investigational Site
  • 511.84.01002 Boehringer Ingelheim Investigational Site
  • 511.84.01069 Boehringer Ingelheim Investigational Site
  • 511.84.01007 Boehringer Ingelheim Investigational Site
  • 511.84.01055 Boehringer Ingelheim Investigational Site
  • 511.84.01064 Boehringer Ingelheim Investigational Site
  • 511.84.01182 Boehringer Ingelheim Investigational Site
  • 511.84.01167 Boehringer Ingelheim Investigational Site
  • 511.84.01111 Boehringer Ingelheim Investigational Site
  • 511.84.01118 Boehringer Ingelheim Investigational Site
  • 511.84.01135 Boehringer Ingelheim Investigational Site
  • 511.84.01032 Boehringer Ingelheim Investigational Site
  • 511.84.01175 Boehringer Ingelheim Investigational Site
  • 511.84.01053 Boehringer Ingelheim Investigational Site
  • 511.84.01132 Boehringer Ingelheim Investigational Site
  • 511.84.01117 Boehringer Ingelheim Investigational Site
  • 511.84.01159 Boehringer Ingelheim Investigational Site
  • 511.84.01170 Boehringer Ingelheim Investigational Site
  • 511.84.01183 Boehringer Ingelheim Investigational Site
  • 511.84.01003 Boehringer Ingelheim Investigational Site
  • 511.84.01022 Boehringer Ingelheim Investigational Site
  • 511.84.01024 Boehringer Ingelheim Investigational Site
  • 511.84.01061 Boehringer Ingelheim Investigational Site
  • 511.84.01205 Boehringer Ingelheim Investigational Site
  • 511.84.01176 Boehringer Ingelheim Investigational Site
  • 511.84.01139 Boehringer Ingelheim Investigational Site
  • 511.84.01023 Boehringer Ingelheim Investigational Site
  • 511.84.01179 Boehringer Ingelheim Investigational Site
  • 511.84.01113 Boehringer Ingelheim Investigational Site
  • 511.84.01165 Boehringer Ingelheim Investigational Site
  • 511.84.01172 Boehringer Ingelheim Investigational Site
  • 511.84.01143 Boehringer Ingelheim Investigational Site
  • 511.84.01092 Boehringer Ingelheim Investigational Site
  • 511.84.01202 Boehringer Ingelheim Investigational Site
  • 511.84.01049 Boehringer Ingelheim Investigational Site
  • 511.84.01025 Boehringer Ingelheim Investigational Site
  • 511.84.01171 Boehringer Ingelheim Investigational Site
  • 511.84.01192 Boehringer Ingelheim Investigational Site
  • 511.84.01130 Boehringer Ingelheim Investigational Site
  • 511.84.01001 Boehringer Ingelheim Investigational Site
  • 511.84.01120 Boehringer Ingelheim Investigational Site
  • 511.84.01030 Boehringer Ingelheim Investigational Site
  • 511.84.01127 Boehringer Ingelheim Investigational Site
  • 511.84.01081 Boehringer Ingelheim Investigational Site
  • 511.84.01147 Boehringer Ingelheim Investigational Site
  • 511.84.01041 Boehringer Ingelheim Investigational Site
  • 511.84.01131 Boehringer Ingelheim Investigational Site
  • 511.84.01128 Boehringer Ingelheim Investigational Site
  • 511.84.01051 Boehringer Ingelheim Investigational Site
  • 511.84.01034 Boehringer Ingelheim Investigational Site
  • 511.84.01042 Boehringer Ingelheim Investigational Site
  • 511.84.01156 Boehringer Ingelheim Investigational Site
  • 511.84.01148 Boehringer Ingelheim Investigational Site
  • 511.84.01206 Boehringer Ingelheim Investigational Site
  • 511.84.01010 Boehringer Ingelheim Investigational Site
  • 511.84.01045 Boehringer Ingelheim Investigational Site
  • 511.84.01059 Boehringer Ingelheim Investigational Site
  • 511.84.01050 Boehringer Ingelheim Investigational Site
  • 511.84.01066 Boehringer Ingelheim Investigational Site
  • 511.84.01187 Boehringer Ingelheim Investigational Site
  • 511.84.01038 Boehringer Ingelheim Investigational Site
  • 511.84.01178 Boehringer Ingelheim Investigational Site
  • 511.84.01121 Boehringer Ingelheim Investigational Site
  • 511.84.01119 Boehringer Ingelheim Investigational Site
  • 511.84.01072 Boehringer Ingelheim Investigational Site
  • 511.84.01106 Boehringer Ingelheim Investigational Site
  • 511.84.01008 Boehringer Ingelheim Investigational Site
  • 511.84.01062 Boehringer Ingelheim Investigational Site
  • 511.84.01089 Boehringer Ingelheim Investigational Site
  • 511.84.01197 Boehringer Ingelheim Investigational Site
  • 511.84.01201 Boehringer Ingelheim Investigational Site
  • 511.84.01009 Boehringer Ingelheim Investigational Site
  • 511.84.01014 Boehringer Ingelheim Investigational Site
  • 511.84.01152 Boehringer Ingelheim Investigational Site
  • 511.84.01136 Boehringer Ingelheim Investigational Site
  • 511.84.01149 Boehringer Ingelheim Investigational Site
  • 511.84.01151 Boehringer Ingelheim Investigational Site
  • 511.84.01150 Boehringer Ingelheim Investigational Site
  • 511.84.01190 Boehringer Ingelheim Investigational Site
  • 511.84.01112 Planned Parenthood of Arkansas & Estrn Oklahoma, Inc
  • 511.84.01185 Boehringer Ingelheim Investigational Site
  • 511.84.01019 Boehringer Ingelheim Investigational Site
  • 511.84.01134 Boehringer Ingelheim Investigational Site
  • 511.84.01103 Boehringer Ingelheim Investigational Site
  • 511.84.01088 Boehringer Ingelheim Investigational Site
  • 511.84.01067 Boehringer Ingelheim Investigational Site
  • 511.84.01153 Boehringer Ingelheim Investigational Site
  • 511.84.01145 Boehringer Ingelheim Investigational Site
  • 511.84.01054 Boehringer Ingelheim Investigational Site
  • 511.84.01021 Boehringer Ingelheim Investigational Site
  • 511.84.01060 Boehringer Ingelheim Investigational Site
  • 511.84.01063 Boehringer Ingelheim Investigational Site
  • 511.84.01124 Boehringer Ingelheim Investigational Site
  • 511.84.01123 Boehringer Ingelheim Investigational Site
  • 511.84.01109 Boehringer Ingelheim Investigational Site
  • 511.84.01174 Boehringer Ingelheim Investigational Site
  • 511.84.01163 Boehringer Ingelheim Investigational Site
  • 511.84.01026 Boehringer Ingelheim Investigational Site
  • 511.84.01100 Boehringer Ingelheim Investigational Site
  • 511.84.01078 Boehringer Ingelheim Investigational Site
  • 511.84.01052 Boehringer Ingelheim Investigational Site
  • 511.84.01027 Boehringer Ingelheim Investigational Site
  • 511.84.01140 Boehringer Ingelheim Investigational Site
  • 511.84.01084 Boehringer Ingelheim Investigational Site
  • 511.84.01057 Boehringer Ingelheim Investigational Site
  • 511.84.01082 Boehringer Ingelheim Investigational Site
  • 511.84.01198 Boehringer Ingelheim Investigational Site
  • 511.84.01036 Boehringer Ingelheim Investigational Site
  • 511.84.01071 Boehringer Ingelheim Investigational Site
  • 511.84.01083 Boehringer Ingelheim Investigational Site
  • 511.84.01086 Boehringer Ingelheim Investigational Site
  • 511.84.01098 Boehringer Ingelheim Investigational Site
  • 511.84.01015 Boehringer Ingelheim Investigational Site
  • 511.84.01180 Boehringer Ingelheim Investigational Site
  • 511.84.01028 Boehringer Ingelheim Investigational Site
  • 511.84.01031 Boehringer Ingelheim Investigational Site
  • 511.84.01035 Boehringer Ingelheim Investigational Site
  • 511.84.01107 Boehringer Ingelheim Investigational Site
  • 511.84.01125 Boehringer Ingelheim Investigational Site
  • 511.84.01076 Boehringer Ingelheim Investigational Site
  • 511.84.01097 Boehringer Ingelheim Investigational Site
  • 511.84.01196 Boehringer Ingelheim Investigational Site
  • 511.84.01093 Boehringer Ingelheim Investigational Site
  • 511.84.01141 Boehringer Ingelheim Investigational Site
  • 511.84.01012 Boehringer Ingelheim Investigational Site
  • 511.84.01116 Boehringer Ingelheim Investigational Site
  • 511.84.01105 Boehringer Ingelheim Investigational Site
  • 511.84.01177 Boehringer Ingelheim Investigational Site
  • 511.84.02007 Boehringer Ingelheim Investigational Site
  • 511.84.02014 Boehringer Ingelheim Investigational Site
  • 511.84.02002 Boehringer Ingelheim Investigational Site
  • 511.84.02021 Boehringer Ingelheim Investigational Site
  • 511.84.02013 Boehringer Ingelheim Investigational Site
  • 511.84.02015 Boehringer Ingelheim Investigational Site
  • 511.84.02023 Boehringer Ingelheim Investigational Site
  • 511.84.02017 Boehringer Ingelheim Investigational Site
  • 511.84.02010 Boehringer Ingelheim Investigational Site
  • 511.84.02012 Boehringer Ingelheim Investigational Site
  • 511.84.02006 Boehringer Ingelheim Investigational Site
  • 511.84.02003 Boehringer Ingelheim Investigational Site
  • 511.84.02018 Boehringer Ingelheim Investigational Site
  • 511.84.02009 Boehringer Ingelheim Investigational Site
  • 511.84.02022 Boehringer Ingelheim Investigational Site
  • 511.84.02024 Boehringer Ingelheim Investigational Site
  • 511.84.02001 Boehringer Ingelheim Investigational Site
  • 511.84.02008 Boehringer Ingelheim Investigational Site
  • 511.84.02011 Boehringer Ingelheim Investigational Site
  • 511.84.02019 Boehringer Ingelheim Investigational Site
  • 511.84.02005 Boehringer Ingelheim Investigational Site
  • 511.84.02004 Boehringer Ingelheim Investigational Site
  • 511.84.02020 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

flibanserin

Arm Description

flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.

Outcomes

Primary Outcome Measures

The Frequency of Adverse Events (Side Effects).
This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder

Secondary Outcome Measures

Full Information

First Posted
February 28, 2007
Last Updated
May 14, 2014
Sponsor
Sprout Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00441558
Brief Title
A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).
Official Title
Worldwide One-year Open-label Safety Study of Flibanserin in Women With HSDD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
terminated for administrative reasons
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (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 determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.

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
1723 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flibanserin
Arm Type
Experimental
Arm Description
flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Flibanserin
Intervention Description
flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Primary Outcome Measure Information:
Title
The Frequency of Adverse Events (Side Effects).
Description
This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder
Time Frame
52 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 with a primary diagnosis of HSDD who have completed a previous study of Flibanserin. Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study. Patients must be reliable, compliant, and agree to cooperate with all study evaluations. Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff. Exclusion Criteria: A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt. Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin. Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy. Patients who are pregnant or have been pregnant within 1 month prior to study start. Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD. Clinically significant ECG or lab abnormalities at study start. Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.
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
511.84.01079 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
511.84.01193 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
511.84.01188 Boehringer Ingelheim Investigational Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
511.84.01110 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
511.84.01142 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
511.84.01157 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
511.84.01162 Boehringer Ingelheim Investigational Site
City
Little Rock
State/Province
Alaska
Country
United States
Facility Name
511.84.01070 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
511.84.01191 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
511.84.01115 Boehringer Ingelheim Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
511.84.01013 Boehringer Ingelheim Investigational Site
City
Jonesboro
State/Province
Arkansas
Country
United States
Facility Name
511.84.01087 Boehringer Ingelheim Investigational Site
City
Berkeley
State/Province
California
Country
United States
Facility Name
511.84.01077 Boehringer Ingelheim Investigational Site
City
Encinitas
State/Province
California
Country
United States
Facility Name
511.84.01074 Boehringer Ingelheim Investigational Site
City
Fair Oaks
State/Province
California
Country
United States
Facility Name
511.84.01104 Boehringer Ingelheim Investigational Site
City
Irvine
State/Province
California
Country
United States
Facility Name
511.84.01037 Boehringer Ingelheim Investigational Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
511.84.01056 Boehringer Ingelheim Investigational Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
511.84.01195 Boehringer Ingelheim Investigational Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
511.84.01043 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.84.01047 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.84.01096 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.84.01040 Boehringer Ingelheim Investigational Site
City
Stanford
State/Province
California
Country
United States
Facility Name
511.84.01048 Boehringer Ingelheim Investigational Site
City
Tarzana
State/Province
California
Country
United States
Facility Name
511.84.01017 Boehringer Ingelheim Investigational Site
City
Torrance
State/Province
California
Country
United States
Facility Name
511.84.01173 Boehringer Ingelheim Investigational Site
City
Vista
State/Province
California
Country
United States
Facility Name
511.84.01029 Boehringer Ingelheim Investigational Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
511.84.01137 Boehringer Ingelheim Investigational Site
City
Westlake Village
State/Province
California
Country
United States
Facility Name
511.84.01090 Boehringer Ingelheim Investigational Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
511.84.01164 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
511.84.01184 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
511.84.01004 Boehringer Ingelheim Investigational Site
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
511.84.01006 Boehringer Ingelheim Investigational Site
City
Wheatridge
State/Province
Colorado
Country
United States
Facility Name
511.84.01138 Boehringer Ingelheim Investigational Site
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
511.84.01044 Boehringer Ingelheim Investigational Site
City
Groton
State/Province
Connecticut
Country
United States
Facility Name
511.84.01016 Boehringer Ingelheim Investigational Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
511.84.01108 Boehringer Ingelheim Investigational Site
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
511.84.01168 Boehringer Ingelheim Investigational Site
City
New London
State/Province
Connecticut
Country
United States
Facility Name
511.84.01166 Boehringer Ingelheim Investigational Site
City
Newark
State/Province
Delaware
Country
United States
Facility Name
511.84.01160 Boehringer Ingelheim Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
511.84.01065 Boehringer Ingelheim Investigational Site
City
Aventura
State/Province
Florida
Country
United States
Facility Name
511.84.01005 Boehringer Ingelheim Investigational Site
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
511.84.01146 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
511.84.01144 Boehringer Ingelheim Investigational Site
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
511.84.01169 Boehringer Ingelheim Investigational Site
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
511.84.01085 Boehringer Ingelheim Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
511.84.01194 Boehringer Ingelheim Investigational Site
City
Fort Meyers
State/Province
Florida
Country
United States
Facility Name
511.84.01002 Boehringer Ingelheim Investigational Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
511.84.01069 Boehringer Ingelheim Investigational Site
City
Gainsville
State/Province
Florida
Country
United States
Facility Name
511.84.01007 Boehringer Ingelheim Investigational Site
City
Hudson
State/Province
Florida
Country
United States
Facility Name
511.84.01055 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
511.84.01064 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
511.84.01182 Boehringer Ingelheim Investigational Site
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
511.84.01167 Boehringer Ingelheim Investigational Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
511.84.01111 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
511.84.01118 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
511.84.01135 Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
511.84.01032 Boehringer Ingelheim Investigational Site
City
Plantation
State/Province
Florida
Country
United States
Facility Name
511.84.01175 Boehringer Ingelheim Investigational Site
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
511.84.01053 Boehringer Ingelheim Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
511.84.01132 Boehringer Ingelheim Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
511.84.01117 Boehringer Ingelheim Investigational Site
City
Stuart
State/Province
Florida
Country
United States
Facility Name
511.84.01159 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
511.84.01170 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
511.84.01183 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
511.84.01003 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
511.84.01022 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
511.84.01024 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
511.84.01061 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
511.84.01205 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
511.84.01176 Boehringer Ingelheim Investigational Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
511.84.01139 Boehringer Ingelheim Investigational Site
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
511.84.01023 Boehringer Ingelheim Investigational Site
City
Sandy Springs
State/Province
Georgia
Country
United States
Facility Name
511.84.01179 Boehringer Ingelheim Investigational Site
City
Champaign
State/Province
Illinois
Country
United States
Facility Name
511.84.01113 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
511.84.01165 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
511.84.01172 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
511.84.01143 Boehringer Ingelheim Investigational Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
511.84.01092 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
511.84.01202 Boehringer Ingelheim Investigational Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
511.84.01049 Boehringer Ingelheim Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
511.84.01025 Boehringer Ingelheim Investigational Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
511.84.01171 Boehringer Ingelheim Investigational Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
511.84.01192 Boehringer Ingelheim Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
511.84.01130 Boehringer Ingelheim Investigational Site
City
New Orlean
State/Province
Louisiana
Country
United States
Facility Name
511.84.01001 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
511.84.01120 Boehringer Ingelheim Investigational Site
City
Brighton
State/Province
Massachusetts
Country
United States
Facility Name
511.84.01030 Boehringer Ingelheim Investigational Site
City
Haverhill
State/Province
Massachusetts
Country
United States
Facility Name
511.84.01127 Boehringer Ingelheim Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
511.84.01081 Boehringer Ingelheim Investigational Site
City
Bingham Farms
State/Province
Michigan
Country
United States
Facility Name
511.84.01147 Boehringer Ingelheim Investigational Site
City
Bingham Farms
State/Province
Michigan
Country
United States
Facility Name
511.84.01041 Boehringer Ingelheim Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
511.84.01131 Boehringer Ingelheim Investigational Site
City
Chaska
State/Province
Minnesota
Country
United States
Facility Name
511.84.01128 Boehringer Ingelheim Investigational Site
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
511.84.01051 Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
511.84.01034 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
511.84.01042 Boehringer Ingelheim Investigational Site
City
Billings
State/Province
Montana
Country
United States
Facility Name
511.84.01156 Boehringer Ingelheim Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
511.84.01148 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
511.84.01206 Boehringer Ingelheim Investigational Site
City
Moorestown
State/Province
New Jersey
Country
United States
Facility Name
511.84.01010 Boehringer Ingelheim Investigational Site
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
511.84.01045 Boehringer Ingelheim Investigational Site
City
Albequerque
State/Province
New Mexico
Country
United States
Facility Name
511.84.01059 Boehringer Ingelheim Investigational Site
City
Bronx
State/Province
New York
Country
United States
Facility Name
511.84.01050 Boehringer Ingelheim Investigational Site
City
Endwell
State/Province
New York
Country
United States
Facility Name
511.84.01066 Boehringer Ingelheim Investigational Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
511.84.01187 Boehringer Ingelheim Investigational Site
City
Purchase
State/Province
New York
Country
United States
Facility Name
511.84.01038 Boehringer Ingelheim Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
511.84.01178 Boehringer Ingelheim Investigational Site
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
511.84.01121 Boehringer Ingelheim Investigational Site
City
New Bern
State/Province
North Carolina
Country
United States
Facility Name
511.84.01119 Boehringer Ingelheim Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
511.84.01072 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
511.84.01106 Boehringer Ingelheim Investigational Site
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
511.84.01008 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.84.01062 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.84.01089 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.84.01197 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.84.01201 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.84.01009 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
511.84.01014 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
511.84.01152 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
511.84.01136 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
511.84.01149 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
511.84.01151 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
511.84.01150 Boehringer Ingelheim Investigational Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
511.84.01190 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
511.84.01112 Planned Parenthood of Arkansas & Estrn Oklahoma, Inc
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
511.84.01185 Boehringer Ingelheim Investigational Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
511.84.01019 Boehringer Ingelheim Investigational Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
511.84.01134 Boehringer Ingelheim Investigational Site
City
Medfod
State/Province
Oregon
Country
United States
Facility Name
511.84.01103 Boehringer Ingelheim Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
511.84.01088 Boehringer Ingelheim Investigational Site
City
Jenkintown
State/Province
Pennsylvania
Country
United States
Facility Name
511.84.01067 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
511.84.01153 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
511.84.01145 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
511.84.01054 Boehringer Ingelheim Investigational Site
City
West Reading
State/Province
Pennsylvania
Country
United States
Facility Name
511.84.01021 Boehringer Ingelheim Investigational Site
City
Wilkes-Barre
State/Province
Pennsylvania
Country
United States
Facility Name
511.84.01060 Boehringer Ingelheim Investigational Site
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
511.84.01063 Boehringer Ingelheim Investigational Site
City
Anderson
State/Province
South Carolina
Country
United States
Facility Name
511.84.01124 Boehringer Ingelheim Investigational Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
511.84.01123 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
511.84.01109 Boehringer Ingelheim Investigational Site
City
Mt. Pleasant
State/Province
South Carolina
Country
United States
Facility Name
511.84.01174 Boehringer Ingelheim Investigational Site
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
511.84.01163 Boehringer Ingelheim Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
511.84.01026 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
511.84.01100 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
511.84.01078 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
511.84.01052 Boehringer Ingelheim Investigational Site
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
511.84.01027 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
511.84.01140 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
511.84.01084 Boehringer Ingelheim Investigational Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
511.84.01057 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
511.84.01082 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
511.84.01198 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
511.84.01036 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.84.01071 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.84.01083 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.84.01086 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.84.01098 Boehringer Ingelheim Investigational Site
City
Waco
State/Province
Texas
Country
United States
Facility Name
511.84.01015 Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
511.84.01180 Boehringer Ingelheim Investigational Site
City
Sandy
State/Province
Utah
Country
United States
Facility Name
511.84.01028 Boehringer Ingelheim Investigational Site
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
511.84.01031 Boehringer Ingelheim Investigational Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
511.84.01035 Boehringer Ingelheim Investigational Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
511.84.01107 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
511.84.01125 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
511.84.01076 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.84.01097 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.84.01196 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.84.01093 Boehringer Ingelheim Investigational Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
511.84.01141 Boehringer Ingelheim Investigational Site
City
Renton
State/Province
Washington
Country
United States
Facility Name
511.84.01012 Boehringer Ingelheim Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
511.84.01116 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
511.84.01105 Boehringer Ingelheim Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
511.84.01177 Boehringer Ingelheim Investigational Site
City
Middleton
State/Province
Wisconsin
Country
United States
Facility Name
511.84.02007 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
511.84.02014 Boehringer Ingelheim Investigational Site
City
Coquitlam
State/Province
British Columbia
Country
Canada
Facility Name
511.84.02002 Boehringer Ingelheim Investigational Site
City
North Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
511.84.02021 Boehringer Ingelheim Investigational Site
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
511.84.02013 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
511.84.02015 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
511.84.02023 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
511.84.02017 Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
511.84.02010 Boehringer Ingelheim Investigational Site
City
Woodstock
State/Province
New Brunswick
Country
Canada
Facility Name
511.84.02012 Boehringer Ingelheim Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
511.84.02006 Boehringer Ingelheim Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
511.84.02003 Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
511.84.02018 Boehringer Ingelheim Investigational Site
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
511.84.02009 Boehringer Ingelheim Investigational Site
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
511.84.02022 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
511.84.02024 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
511.84.02001 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
511.84.02008 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
511.84.02011 Boehringer Ingelheim Investigational Site
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
511.84.02019 Boehringer Ingelheim Investigational Site
City
Québec
State/Province
Quebec
Country
Canada
Facility Name
511.84.02005 Boehringer Ingelheim Investigational Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
511.84.02004 Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
511.84.02020 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23057791
Citation
Jayne C, Simon JA, Taylor LV, Kimura T, Lesko LM; SUNFLOWER study investigators. Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. J Sex Med. 2012 Dec;9(12):3180-8. doi: 10.1111/j.1743-6109.2012.02942.x. Epub 2012 Oct 11.
Results Reference
derived

Learn more about this trial

A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

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