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Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

Primary Purpose

Sexual Dysfunctions, Psychological

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • Naturally postmenopausal women of any age with at least one ovary
  • Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration
  • Stable, monogamous heterosexual relationship for at least one year
  • Willing to discuss sexual issues
  • Willing to engage in sexual activity at least once a month
  • Normal Pap smear
  • Normal mammogram
  • Normal uterine lining
  • Able to comply with daily use of handheld data entry device

Exclusion criteria:

  • Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
  • Partner with inadequately treated organic or psychosexual dysfunction
  • Sexual function impaired by psychiatric disorder
  • Sexual function impaired by gynecological disorder
  • Major Depression
  • Suicidal behavior or ideation
  • Major life stress that could impair sexual function
  • Substance abuse

Sites / Locations

  • 511.156.01059 Boehringer Ingelheim Investigational Site
  • 511.156.01084 Boehringer Ingelheim Investigational Site
  • 511.156.01053 Boehringer Ingelheim Investigational Site
  • 511.156.01069 Boehringer Ingelheim Investigational Site
  • 511.156.01063 Boehringer Ingelheim Investigational Site
  • 511.156.01076 Boehringer Ingelheim Investigational Site
  • 511.156.01039 Boehringer Ingelheim Investigational Site
  • 511.156.01070 Boehringer Ingelheim Investigational Site
  • 511.156.01075 Boehringer Ingelheim Investigational Site
  • 511.156.01087 Boehringer Ingelheim Investigational Site
  • 511.156.01064 Boehringer Ingelheim Investigational Site
  • 511.156.01016 Boehringer Ingelheim Investigational Site
  • 511.156.01007 Boehringer Ingelheim Investigational Site
  • 511.156.01038 Boehringer Ingelheim Investigational Site
  • 511.156.01067 Boehringer Ingelheim Investigational Site
  • 511.156.01036 Boehringer Ingelheim Investigational Site
  • 511.156.01092 Boehringer Ingelheim Investigational Site
  • 511.156.01027 Boehringer Ingelheim Investigational Site
  • 511.156.01022 Boehringer Ingelheim Investigational Site
  • 511.156.01042 Boehringer Ingelheim Investigational Site
  • 511.156.01047 Boehringer Ingelheim Investigational Site
  • 511.156.01051 Boehringer Ingelheim Investigational Site
  • 511.156.01011 Boehringer Ingelheim Investigational Site
  • 511.156.01078 Boehringer Ingelheim Investigational Site
  • 511.156.01095 Boehringer Ingelheim Investigational Site
  • 511.156.01046 Boehringer Ingelheim Investigational Site
  • 511.156.01056 Boehringer Ingelheim Investigational Site
  • 511.156.01045 Boehringer Ingelheim Investigational Site
  • 511.156.01021 Boehringer Ingelheim Investigational Site
  • 511.156.01081 Boehringer Ingelheim Investigational Site
  • 511.156.01066 Boehringer Ingelheim Investigational Site
  • 511.156.01025 Boehringer Ingelheim Investigational Site
  • 511.156.01028 Boehringer Ingelheim Investigational Site
  • 511.156.01089 Boehringer Ingelheim Investigational Site
  • 511.156.01010 Boehringer Ingelheim Investigational Site
  • 511.156.01008 Boehringer Ingelheim Investigational Site
  • 511.156.01034 Boehringer Ingelheim Investigational Site
  • 511.156.01012 Boehringer Ingelheim Investigational Site
  • 511.156.01074 Boehringer Ingelheim Investigational Site
  • 511.156.01079 Boehringer Ingelheim Investigational Site
  • 511.156.01080 Boehringer Ingelheim Investigational Site
  • 511.156.01006 Boehringer Ingelheim Investigational Site
  • 511.156.01086 Boehringer Ingelheim Investigational Site
  • 511.156.01005 Boehringer Ingelheim Investigational Site
  • 511.156.01013 Boehringer Ingelheim Investigational Site
  • 511.156.01088 Boehringer Ingelheim Investigational Site
  • 511.156.01001 Boehringer Ingelheim Investigational Site
  • 511.156.01055 Boehringer Ingelheim Investigational Site
  • 511.156.01009 Boehringer Ingelheim Investigational Site
  • 511.156.01037 Boehringer Ingelheim Investigational Site
  • 511.156.01031 Boehringer Ingelheim Investigational Site
  • 511.156.01024 Boehringer Ingelheim Investigational Site
  • 511.156.01065 Boehringer Ingelheim Investigational Site
  • 511.156.01029 Boehringer Ingelheim Investigational Site
  • 511.156.01002 Boehringer Ingelheim Investigational Site
  • 511.156.01040 Boehringer Ingelheim Investigational Site
  • 511.156.01026 Boehringer Ingelheim Investigational Site
  • 511.156.01093 Boehringer Ingelheim Investigational Site
  • 511.156.01052 Boehringer Ingelheim Investigational Site
  • 511.156.01017 Boehringer Ingelheim Investigational Site
  • 511.156.01032 Boehringer Ingelheim Investigational Site
  • 511.156.01033 Boehringer Ingelheim Investigational Site
  • 511.156.01068 Boehringer Ingelheim Investigational Site
  • 511.156.01077 Boehringer Ingelheim Investigational Site
  • 511.156.01072 Boehringer Ingelheim Investigational Site
  • 511.156.01082 Boehringer Ingelheim Investigational Site
  • 511.156.01094 Boehringer Ingelheim Investigational Site
  • 511.156.01083 Boehringer Ingelheim Investigational Site
  • 511.156.01048 Boehringer Ingelheim Investigational Site
  • 511.156.01058 Boehringer Ingelheim Investigational Site
  • 511.156.01085 Boehringer Ingelheim Investigational Site
  • 511.156.01073 Boehringer Ingelheim Investigational Site
  • 511.156.01041 Boehringer Ingelheim Investigational Site
  • 511.156.01035 Boehringer Ingelheim Investigational Site
  • 511.156.01091 Boehringer Ingelheim Investigational Site
  • 511.156.01060 Boehringer Ingelheim Investigational Site
  • 511.156.01003 Boehringer Ingelheim Investigational Site
  • 511.156.01054 Boehringer Ingelheim Investigational Site
  • 511.156.01050 Boehringer Ingelheim Investigational Site
  • 511.156.01014 Boehringer Ingelheim Investigational Site
  • 511.156.01049 Boehringer Ingelheim Investigational Site
  • 511.156.01015 Boehringer Ingelheim Investigational Site
  • 511.156.01090 Boehringer Ingelheim Investigational Site
  • 511.156.01020 Boehringer Ingelheim Investigational Site
  • 511.156.02004 Boehringer Ingelheim Investigational Site
  • 511.156.02010 Boehringer Ingelheim Investigational Site
  • 511.156.02009 Boehringer Ingelheim Investigational Site
  • 511.156.02014 Boehringer Ingelheim Investigational Site
  • 511.156.02012 Boehringer Ingelheim Investigational Site
  • 511.156.02017 Boehringer Ingelheim Investigational Site
  • 511.156.02007 Boehringer Ingelheim Investigational Site
  • 511.156.02008 Boehringer Ingelheim Investigational Site
  • 511.156.02001 Boehringer Ingelheim Investigational Site
  • 511.156.02013 Boehringer Ingelheim Investigational Site
  • 511.156.02006 Boehringer Ingelheim Investigational Site
  • 511.156.02005 Boehringer Ingelheim Investigational Site
  • 511.156.02016 Boehringer Ingelheim Investigational Site
  • 511.156.02015 Boehringer Ingelheim Investigational Site
  • 511.156.02003 Boehringer Ingelheim Investigational Site
  • 511.156.02002 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Flibanserin 100 mg

Placebo

Arm Description

Flibanserin 100 mg administered at bedtime

This is the matched placebo which will be administered two tablets daily at bedtime.

Outcomes

Primary Outcome Measures

Change From Baseline in the Number of Satisfying Sexual Events
The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2010
Last Updated
June 16, 2014
Sponsor
Sprout Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01057901
Brief Title
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America
Official Title
24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Study terminated for administrative reasons.
Study Start Date
January 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
The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.

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
748 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flibanserin 100 mg
Arm Type
Experimental
Arm Description
Flibanserin 100 mg administered at bedtime
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This is the matched placebo which will be administered two tablets daily at bedtime.
Intervention Type
Drug
Intervention Name(s)
Flibanserin
Intervention Description
Flibanserin 100mg administered at bedtime for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
This is the matched placebo which will be administered two tablets daily at bedtime.
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Satisfying Sexual Events
Description
The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
Time Frame
baseline to 24 weeks
Title
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
Description
The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.
Time Frame
baseline to 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Naturally postmenopausal women of any age with at least one ovary Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration Stable, monogamous heterosexual relationship for at least one year Willing to discuss sexual issues Willing to engage in sexual activity at least once a month Normal Pap smear Normal mammogram Normal uterine lining Able to comply with daily use of handheld data entry device Exclusion criteria: Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition Partner with inadequately treated organic or psychosexual dysfunction Sexual function impaired by psychiatric disorder Sexual function impaired by gynecological disorder Major Depression Suicidal behavior or ideation Major life stress that could impair sexual function Substance abuse
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
511.156.01059 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
511.156.01084 Boehringer Ingelheim Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
511.156.01053 Boehringer Ingelheim Investigational Site
City
Tuscon
State/Province
Arizona
Country
United States
Facility Name
511.156.01069 Boehringer Ingelheim Investigational Site
City
Tuscon
State/Province
Arizona
Country
United States
Facility Name
511.156.01063 Boehringer Ingelheim Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
511.156.01076 Boehringer Ingelheim Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
511.156.01039 Boehringer Ingelheim Investigational Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
511.156.01070 Boehringer Ingelheim Investigational Site
City
Berkeley
State/Province
California
Country
United States
Facility Name
511.156.01075 Boehringer Ingelheim Investigational Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
511.156.01087 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
511.156.01064 Boehringer Ingelheim Investigational Site
City
Newport Beach
State/Province
California
Country
United States
Facility Name
511.156.01016 Boehringer Ingelheim Investigational Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
511.156.01007 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.156.01038 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.156.01067 Boehringer Ingelheim Investigational Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
511.156.01036 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
511.156.01092 Boehringer Ingelheim Investigational Site
City
Fort Collins
State/Province
Colorado
Country
United States
Facility Name
511.156.01027 Boehringer Ingelheim Investigational Site
City
New London
State/Province
Connecticut
Country
United States
Facility Name
511.156.01022 Boehringer Ingelheim Investigational Site
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
511.156.01042 Boehringer Ingelheim Investigational Site
City
Deland
State/Province
Florida
Country
United States
Facility Name
511.156.01047 Boehringer Ingelheim Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
511.156.01051 Boehringer Ingelheim Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
511.156.01011 Boehringer Ingelheim Investigational Site
City
Gainseville
State/Province
Florida
Country
United States
Facility Name
511.156.01078 Boehringer Ingelheim Investigational Site
City
Lake Worth
State/Province
Florida
Country
United States
Facility Name
511.156.01095 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
511.156.01046 Boehringer Ingelheim Investigational Site
City
Plantation
State/Province
Florida
Country
United States
Facility Name
511.156.01056 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
511.156.01045 Boehringer Ingelheim Investigational Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
511.156.01021 Boehringer Ingelheim Investigational Site
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
511.156.01081 Boehringer Ingelheim Investigational Site
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
511.156.01066 Boehringer Ingelheim Investigational Site
City
Boise
State/Province
Idaho
Country
United States
Facility Name
511.156.01025 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
511.156.01028 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
511.156.01089 Boehringer Ingelheim Investigational Site
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
511.156.01010 Boehringer Ingelheim Investigational Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
511.156.01008 Boehringer Ingelheim Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
511.156.01034 Boehringer Ingelheim Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
511.156.01012 Boehringer Ingelheim Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
511.156.01074 Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
511.156.01079 Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
511.156.01080 Boehringer Ingelheim Investigational Site
City
Haverhill
State/Province
Massachusetts
Country
United States
Facility Name
511.156.01006 Boehringer Ingelheim Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
511.156.01086 Boehringer Ingelheim Investigational Site
City
Paw Paw
State/Province
Michigan
Country
United States
Facility Name
511.156.01005 Boehringer Ingelheim Investigational Site
City
Chaska
State/Province
Minnesota
Country
United States
Facility Name
511.156.01013 Boehringer Ingelheim Investigational Site
City
Olive Branch
State/Province
Mississippi
Country
United States
Facility Name
511.156.01088 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
511.156.01001 Boehringer Ingelheim Investigational Site
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
511.156.01055 Boehringer Ingelheim Investigational Site
City
Plainsboro
State/Province
New Jersey
Country
United States
Facility Name
511.156.01009 Boehringer Ingelheim Investigational Site
City
Bronx
State/Province
New York
Country
United States
Facility Name
511.156.01037 Boehringer Ingelheim Investigational Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
511.156.01031 Boehringer Ingelheim Investigational Site
City
Purchase
State/Province
New York
Country
United States
Facility Name
511.156.01024 Boehringer Ingelheim Investigational Site
City
Cary
State/Province
North Carolina
Country
United States
Facility Name
511.156.01065 Boehringer Ingelheim Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
511.156.01029 Boehringer Ingelheim Investigational Site
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
511.156.01002 Boehringer Ingelheim Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
511.156.01040 Boehringer Ingelheim Investigational Site
City
Statesville
State/Province
North Carolina
Country
United States
Facility Name
511.156.01026 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
511.156.01093 Boehringer Ingelheim Investigational Site
City
Bismarck
State/Province
North Dakota
Country
United States
Facility Name
511.156.01052 Boehringer Ingelheim Investigational Site
City
Fargo
State/Province
North Dakota
Country
United States
Facility Name
511.156.01017 Boehringer Ingelheim Investigational Site
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
511.156.01032 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.156.01033 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.156.01068 Boehringer Ingelheim Investigational Site
City
Englewood
State/Province
Ohio
Country
United States
Facility Name
511.156.01077 Boehringer Ingelheim Investigational Site
City
Ashland
State/Province
Oregon
Country
United States
Facility Name
511.156.01072 Boehringer Ingelheim Investigational Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
511.156.01082 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
511.156.01094 Boehringer Ingelheim Investigational Site
City
West Reading
State/Province
Pennsylvania
Country
United States
Facility Name
511.156.01083 Boehringer Ingelheim Investigational Site
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
511.156.01048 Boehringer Ingelheim Investigational Site
City
Anderson
State/Province
South Carolina
Country
United States
Facility Name
511.156.01058 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
511.156.01085 Boehringer Ingelheim Investigational Site
City
Watertown
State/Province
South Dakota
Country
United States
Facility Name
511.156.01073 Boehringer Ingelheim Investigational Site
City
Bristol
State/Province
Tennessee
Country
United States
Facility Name
511.156.01041 Boehringer Ingelheim Investigational Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
511.156.01035 Boehringer Ingelheim Investigational Site
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
511.156.01091 Boehringer Ingelheim Investigational Site
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
511.156.01060 Boehringer Ingelheim Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
511.156.01003 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
511.156.01054 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
511.156.01050 Boehringer Ingelheim Investigational Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
511.156.01014 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
511.156.01049 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.156.01015 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.156.01090 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.156.01020 Boehringer Ingelheim Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
511.156.02004 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
511.156.02010 Boehringer Ingelheim Investigational Site
City
Coquitlam
State/Province
British Columbia
Country
Canada
Facility Name
511.156.02009 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
511.156.02014 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
511.156.02012 Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
511.156.02017 Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
511.156.02007 Boehringer Ingelheim Investigational Site
City
Woodstock
State/Province
New Brunswick
Country
Canada
Facility Name
511.156.02008 Boehringer Ingelheim Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
511.156.02001 Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
511.156.02013 Boehringer Ingelheim Investigational Site
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
511.156.02006 Boehringer Ingelheim Investigational Site
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
511.156.02005 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
511.156.02016 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
511.156.02015 Boehringer Ingelheim Investigational Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
511.156.02003 Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
511.156.02002 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28583342
Citation
Portman DJ, Brown L, Yuan J, Kissling R, Kingsberg SA. Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the PLUMERIA Study. J Sex Med. 2017 Jun;14(6):834-842. doi: 10.1016/j.jsxm.2017.03.258.
Results Reference
derived

Learn more about this trial

Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

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