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Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

Primary Purpose

Sexual Dysfunctions, Psychological

Status
Completed
Phase
Phase 3
Locations
United States
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

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

Inclusion criteria:

  1. Premenopausal women who are 18 years old and older
  2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
  3. Stable, monogamous heterosexual relationship for at least one year.
  4. Willing to discuss sexual issues.
  5. Willing to engage in sexual activity at least once a month
  6. Normal pap smear
  7. Must use medically acceptable method of contraception
  8. Able to comply with daily use of a handheld entry device

Exclusion criteria:

  1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
  2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
  3. Partner with inadequately treated organic or psychosexual dysfunction
  4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
  5. Sexual function impaired by psychiatric disorder
  6. Sexual function impaired by gynecological disorder
  7. Major life stress that could impair sexual function
  8. Substance abuse

Sites / Locations

  • 511.147.01074 Boehringer Ingelheim Investigational Site
  • 511.147.01046 Boehringer Ingelheim Investigational Site
  • 511.147.01042 Boehringer Ingelheim Investigational Site
  • 511.147.01025 Boehringer Ingelheim Investigational Site
  • 511.147.01073 Boehringer Ingelheim Investigational Site
  • 511.147.01030 Boehringer Ingelheim Investigational Site
  • 511.147.01028 Boehringer Ingelheim Investigational Site
  • 511.147.01037 Boehringer Ingelheim Investigational Site
  • 511.147.01022 Boehringer Ingelheim Investigational Site
  • 511.147.01035 Boehringer Ingelheim Investigational Site
  • 511.147.01052 Boehringer Ingelheim Investigational Site
  • 511.147.01016 Boehringer Ingelheim Investigational Site
  • 511.147.01021 Boehringer Ingelheim Investigational Site
  • 511.147.01051 Boehringer Ingelheim Investigational Site
  • 511.147.01071 Boehringer Ingelheim Investigational Site
  • 511.147.01053 Boehringer Ingelheim Investigational Site
  • 511.147.01015 Boehringer Ingelheim Investigational Site
  • 511.147.01041 Boehringer Ingelheim Investigational Site
  • 511.147.01064 Boehringer Ingelheim Investigational Site
  • 511.147.01062 Boehringer Ingelheim Investigational Site
  • 511.147.01003 Boehringer Ingelheim Investigational Site
  • 511.147.01056 Boehringer Ingelheim Investigational Site
  • 511.147.01065 Boehringer Ingelheim Investigational Site
  • 511.147.01020 Boehringer Ingelheim Investigational Site
  • 511.147.01024 Boehringer Ingelheim Investigational Site
  • 511.147.01070 Boehringer Ingelheim Investigational Site
  • 511.147.01043 Boehringer Ingelheim Investigational Site
  • 511.147.01019 Boehringer Ingelheim Investigational Site
  • 511.147.01061 Boehringer Ingelheim Investigational Site
  • 511.147.01066 Boehringer Ingelheim Investigational Site
  • 511.147.01001 Boehringer Ingelheim Investigational Site
  • 511.147.01002 Boehringer Ingelheim Investigational Site
  • 511.147.01009 Boehringer Ingelheim Investigational Site
  • 511.147.01023 Boehringer Ingelheim Investigational Site
  • 511.147.01008 Boehringer Ingelheim Investigational Site
  • 511.147.01044 Boehringer Ingelheim Investigational Site
  • 511.147.01034 Boehringer Ingelheim Investigational Site
  • 511.147.01067 Boehringer Ingelheim Investigational Site
  • 511.147.01013 Boehringer Ingelheim Investigational Site
  • 511.147.01031 Boehringer Ingelheim Investigational Site
  • 511.147.01006 Boehringer Ingelheim Investigational Site
  • 511.147.01014 Boehringer Ingelheim Investigational Site
  • 511.147.01060 Boehringer Ingelheim Investigational Site
  • 511.147.01057 Boehringer Ingelheim Investigational Site
  • 511.147.01039 Boehringer Ingelheim Investigational Site
  • 511.147.01017 Boehringer Ingelheim Investigational Site
  • 511.147.01047 Boehringer Ingelheim Investigational Site
  • 511.147.01027 Boehringer Ingelheim Investigational Site
  • 511.147.01033 Boehringer Ingelheim Investigational Site
  • 511.147.01004 Boehringer Ingelheim Investigational Site
  • 511.147.01050 Boehringer Ingelheim Investigational Site
  • 511.147.01059 Boehringer Ingelheim Investigational Site
  • 511.147.01058 Boehringer Ingelheim Investigational Site
  • 511.147.01072 Boehringer Ingelheim Investigational Site
  • 511.147.01007 Boehringer Ingelheim Investigational Site
  • 511.147.01055 Boehringer Ingelheim Investigational Site
  • 511.147.01048 Boehringer Ingelheim Investigational Site
  • 511.147.01068 Boehringer Ingelheim Investigational Site
  • 511.147.01063 Boehringer Ingelheim Investigational Site
  • 511.147.01010 Boehringer Ingelheim Investigational Site
  • 511.147.01036 Boehringer Ingelheim Investigational Site
  • 511.147.01018 Boehringer Ingelheim Investigational Site
  • 511.147.01032 Boehringer Ingelheim Investigational Site
  • 511.147.01011 Boehringer Ingelheim Investigational Site
  • 511.147.01012 Boehringer Ingelheim Investigational Site
  • 511.147.01026 Boehringer Ingelheim Investigational Site
  • 511.147.01005 Boehringer Ingelheim Investigational Site
  • 511.147.01069 Boehringer Ingelheim Investigational Site
  • 511.147.01040 Boehringer Ingelheim Investigational Site
  • 511.147.01049 Boehringer Ingelheim Investigational Site
  • 511.147.01029 Boehringer Ingelheim Investigational Site
  • 511.147.01075 Boehringer Ingelheim Investigational Site
  • 511.147.01054 Boehringer Ingelheim Investigational Site
  • 511.147.01045 Boehringer Ingelheim Investigational Site
  • 511.147.01038 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 100mg po qd

placebo 1 tab po qd

Outcomes

Primary Outcome Measures

The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.
The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 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 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.
Change From Baseline in the SSE Count From Baseline to 24 Weeks
The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The 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. An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2009
Last Updated
April 16, 2014
Sponsor
Sprout Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00996164
Brief Title
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
Official Title
A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the United States
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 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 object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal 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
1090 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flibanserin 100 mg
Arm Type
Experimental
Arm Description
flibanserin 100mg po qd
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo 1 tab po qd
Intervention Type
Drug
Intervention Name(s)
Flibanserin
Intervention Description
patients will be randomized to flibanserin or placebo in a double-blind manner
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
patients will be randomized to flibanserin or placebo in a double-blind manner
Primary Outcome Measure Information:
Title
The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.
Description
The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 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 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.
Time Frame
24 weeks
Title
Change From Baseline in the SSE Count From Baseline to 24 Weeks
Description
The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The 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. An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.
Time Frame
24 weeks

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: Premenopausal women who are 18 years old and older Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in 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 Must use medically acceptable method of contraception Able to comply with daily use of a handheld entry device Exclusion criteria: Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition. Partner with inadequately treated organic or psychosexual dysfunction History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior. Sexual function impaired by psychiatric disorder Sexual function impaired by gynecological disorder 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
511.147.01074 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
511.147.01046 Boehringer Ingelheim Investigational Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
511.147.01042 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
511.147.01025 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
511.147.01073 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
511.147.01030 Boehringer Ingelheim Investigational Site
City
Encinitas
State/Province
California
Country
United States
Facility Name
511.147.01028 Boehringer Ingelheim Investigational Site
City
Fair Oaks
State/Province
California
Country
United States
Facility Name
511.147.01037 Boehringer Ingelheim Investigational Site
City
Irvine
State/Province
California
Country
United States
Facility Name
511.147.01022 Boehringer Ingelheim Investigational Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
511.147.01035 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.147.01052 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.147.01016 Boehringer Ingelheim Investigational Site
City
Torrance
State/Province
California
Country
United States
Facility Name
511.147.01021 Boehringer Ingelheim Investigational Site
City
Vista
State/Province
California
Country
United States
Facility Name
511.147.01051 Boehringer Ingelheim Investigational Site
City
Westlake Village
State/Province
California
Country
United States
Facility Name
511.147.01071 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
511.147.01053 Boehringer Ingelheim Investigational Site
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
511.147.01015 Boehringer Ingelheim Investigational Site
City
Groton
State/Province
Connecticut
Country
United States
Facility Name
511.147.01041 Boehringer Ingelheim Investigational Site
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
511.147.01064 Boehringer Ingelheim Investigational Site
City
Newark
State/Province
Delaware
Country
United States
Facility Name
511.147.01062 Boehringer Ingelheim Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
511.147.01003 Boehringer Ingelheim Investigational Site
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
511.147.01056 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
511.147.01065 Boehringer Ingelheim Investigational Site
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
511.147.01020 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
511.147.01024 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
511.147.01070 Boehringer Ingelheim Investigational Site
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
511.147.01043 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
511.147.01019 Boehringer Ingelheim Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
511.147.01061 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
511.147.01066 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
511.147.01001 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
511.147.01002 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
511.147.01009 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
511.147.01023 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
511.147.01008 Boehringer Ingelheim Investigational Site
City
Sandy Springs
State/Province
Georgia
Country
United States
Facility Name
511.147.01044 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
511.147.01034 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
511.147.01067 Boehringer Ingelheim Investigational Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
511.147.01013 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
511.147.01031 Boehringer Ingelheim Investigational Site
City
Bingham Farms
State/Province
Michigan
Country
United States
Facility Name
511.147.01006 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
511.147.01014 Boehringer Ingelheim Investigational Site
City
Billings
State/Province
Montana
Country
United States
Facility Name
511.147.01060 Boehringer Ingelheim Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
511.147.01057 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
511.147.01039 Boehringer Ingelheim Investigational Site
City
Moorestown
State/Province
New Jersey
Country
United States
Facility Name
511.147.01017 Boehringer Ingelheim Investigational Site
City
Endwell
State/Province
New York
Country
United States
Facility Name
511.147.01047 Boehringer Ingelheim Investigational Site
City
New Bern
State/Province
North Carolina
Country
United States
Facility Name
511.147.01027 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
511.147.01033 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.147.01004 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
511.147.01050 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
511.147.01059 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
511.147.01058 Boehringer Ingelheim Investigational Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
511.147.01072 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
511.147.01007 Boehringer Ingelheim Investigational Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
511.147.01055 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
511.147.01048 Boehringer Ingelheim Investigational Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
511.147.01068 Boehringer Ingelheim Investigational Site
City
Mt. Pleasant
State/Province
South Carolina
Country
United States
Facility Name
511.147.01063 Boehringer Ingelheim Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
511.147.01010 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
511.147.01036 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
511.147.01018 Boehringer Ingelheim Investigational Site
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
511.147.01032 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
511.147.01011 Boehringer Ingelheim Investigational Site
City
Katy
State/Province
Texas
Country
United States
Facility Name
511.147.01012 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.147.01026 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.147.01005 Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
511.147.01069 Boehringer Ingelheim Investigational Site
City
Sandy
State/Province
Utah
Country
United States
Facility Name
511.147.01040 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
511.147.01049 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
511.147.01029 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.147.01075 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
511.147.01054 Boehringer Ingelheim Investigational Site
City
Renton
State/Province
Washington
Country
United States
Facility Name
511.147.01045 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
511.147.01038 Boehringer Ingelheim Investigational Site
City
Tacoma
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

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