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

Phase 3

Completed

• Conditions: Sexual Dysfunctions, Psychological
• Interventions: Drug: Placebo; Drug: Flibanserin

• Registration Number: NCT00996164
• Lead Sponsor: Sprout Pharmaceuticals, Inc

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Primary Completion: 2010-12
• Study Completion: 2011-02
• Results First Submitted: 2014-03-11
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-16
• Last Update Submitted: 2014-04-16
• Results First Posted: 2014-05-19
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1090

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo 1 tab po qd
flibanserin 100 mg	Flibanserin	flibanserin 100mg po qd

Primary Outcome Measures

Name	Time	Method
The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.	24 weeks	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	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.

Trial Locations

Locations (75)

511.147.01019 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Petersburg, Florida, United States

511.147.01023 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

511.147.01055 Boehringer Ingelheim Investigational Site; 🇺🇸 Pittsburgh, Pennsylvania, United States

511.147.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Cleveland, Ohio, United States

511.147.01032 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

511.147.01020 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

511.147.01024 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

511.147.01034 Boehringer Ingelheim Investigational Site; 🇺🇸 Indianapolis, Indiana, United States

511.147.01033 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

511.147.01035 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

511.147.01036 Boehringer Ingelheim Investigational Site; 🇺🇸 Nashville, Tennessee, United States

511.147.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

511.147.01005 Boehringer Ingelheim Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

511.147.01072 Boehringer Ingelheim Investigational Site; 🇺🇸 Oklahoma City, Oklahoma, United States

511.147.01071 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

511.147.01061 Boehringer Ingelheim Investigational Site; 🇺🇸 Tampa, Florida, United States

511.147.01066 Boehringer Ingelheim Investigational Site; 🇺🇸 Tampa, Florida, United States

511.147.01050 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

511.147.01068 Boehringer Ingelheim Investigational Site; 🇺🇸 Mt. Pleasant, South Carolina, United States

511.147.01016 Boehringer Ingelheim Investigational Site; 🇺🇸 Torrance, California, United States

511.147.01074 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

511.147.01052 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

511.147.01025 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

511.147.01046 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntsville, Alabama, United States

511.147.01073 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

511.147.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 West Palm Beach, Florida, United States

511.147.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 West Palm Beach, Florida, United States

511.147.01014 Boehringer Ingelheim Investigational Site; 🇺🇸 Billings, Montana, United States

511.147.01069 Boehringer Ingelheim Investigational Site; 🇺🇸 Sandy, Utah, United States

511.147.01038 Boehringer Ingelheim Investigational Site; 🇺🇸 Tacoma, Washington, United States

511.147.01011 Boehringer Ingelheim Investigational Site; 🇺🇸 Katy, Texas, United States

511.147.01054 Boehringer Ingelheim Investigational Site; 🇺🇸 Renton, Washington, United States

511.147.01041 Boehringer Ingelheim Investigational Site; 🇺🇸 New Britain, Connecticut, United States

511.147.01037 Boehringer Ingelheim Investigational Site; 🇺🇸 Irvine, California, United States

511.147.01042 Boehringer Ingelheim Investigational Site; 🇺🇸 Mobile, Alabama, United States

511.147.01028 Boehringer Ingelheim Investigational Site; 🇺🇸 Fair Oaks, California, United States

511.147.01030 Boehringer Ingelheim Investigational Site; 🇺🇸 Encinitas, California, United States

511.147.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 Groton, Connecticut, United States

511.147.01053 Boehringer Ingelheim Investigational Site; 🇺🇸 Farmington, Connecticut, United States

511.147.01065 Boehringer Ingelheim Investigational Site; 🇺🇸 Daytona Beach, Florida, United States

511.147.01064 Boehringer Ingelheim Investigational Site; 🇺🇸 Newark, Delaware, United States

511.147.01056 Boehringer Ingelheim Investigational Site; 🇺🇸 Clearwater, Florida, United States

511.147.01008 Boehringer Ingelheim Investigational Site; 🇺🇸 Sandy Springs, Georgia, United States

511.147.01067 Boehringer Ingelheim Investigational Site; 🇺🇸 Lafayette, Louisiana, United States

511.147.01044 Boehringer Ingelheim Investigational Site; 🇺🇸 Chicago, Illinois, United States

511.147.01013 Boehringer Ingelheim Investigational Site; 🇺🇸 Baltimore, Maryland, United States

511.147.01057 Boehringer Ingelheim Investigational Site; 🇺🇸 Las Vegas, Nevada, United States

511.147.01047 Boehringer Ingelheim Investigational Site; 🇺🇸 New Bern, North Carolina, United States

511.147.01060 Boehringer Ingelheim Investigational Site; 🇺🇸 Omaha, Nebraska, United States

511.147.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Louis, Missouri, United States

511.147.01039 Boehringer Ingelheim Investigational Site; 🇺🇸 Moorestown, New Jersey, United States

511.147.01017 Boehringer Ingelheim Investigational Site; 🇺🇸 Endwell, New York, United States

511.147.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 Eugene, Oregon, United States

511.147.01063 Boehringer Ingelheim Investigational Site; 🇺🇸 Knoxville, Tennessee, United States

511.147.01010 Boehringer Ingelheim Investigational Site; 🇺🇸 Nashville, Tennessee, United States

511.147.01018 Boehringer Ingelheim Investigational Site; 🇺🇸 Corpus Christi, Texas, United States

511.147.01026 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

511.147.01031 Boehringer Ingelheim Investigational Site; 🇺🇸 Bingham Farms, Michigan, United States

511.147.01070 Boehringer Ingelheim Investigational Site; 🇺🇸 New Port Richey, Florida, United States

511.147.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Boynton Beach, Florida, United States

511.147.01051 Boehringer Ingelheim Investigational Site; 🇺🇸 Westlake Village, California, United States

511.147.01021 Boehringer Ingelheim Investigational Site; 🇺🇸 Vista, California, United States

511.147.01045 Boehringer Ingelheim Investigational Site; 🇺🇸 Spokane, Washington, United States

511.147.01059 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

511.147.01062 Boehringer Ingelheim Investigational Site; 🇺🇸 Washington, District of Columbia, United States

511.147.01048 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbia, South Carolina, United States

511.147.01009 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

511.147.01049 Boehringer Ingelheim Investigational Site; 🇺🇸 Norfolk, Virginia, United States

511.147.01058 Boehringer Ingelheim Investigational Site; 🇺🇸 Dayton, Ohio, United States

511.147.01040 Boehringer Ingelheim Investigational Site; 🇺🇸 Norfolk, Virginia, United States

511.147.01027 Boehringer Ingelheim Investigational Site; 🇺🇸 Winston-Salem, North Carolina, United States

511.147.01022 Boehringer Ingelheim Investigational Site; 🇺🇸 Sacramento, California, United States

511.147.01043 Boehringer Ingelheim Investigational Site; 🇺🇸 Orlando, Florida, United States

511.147.01075 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States

511.147.01029 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States