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

Phase 3

Terminated

• Conditions: Sexual Dysfunctions, Psychological
• Interventions: Drug: flibanserin

• Registration Number: NCT01103362
• Lead Sponsor: Sprout Pharmaceuticals, Inc

Brief Summary

To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).

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: 2010-04
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2014-04
• Results First Submitted: 2014-04-11
• Results First Submitted QC: 2014-04-11
• Last Update Submitted: 2014-04-11
• Results First Posted: 2014-05-12
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 596

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
flibanserin 100mg	flibanserin	flibanserin 100mg po qd

Primary Outcome Measures

Name	Time	Method
The Frequency of Adverse Events	A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD

Trial Locations

Locations (95)

511.133.01050 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

511.133.01059 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

511.133.01064 Boehringer Ingelheim Investigational Site; 🇺🇸 Newark, Delaware, United States

511.133.01020 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

511.133.01024 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

511.133.01034 Boehringer Ingelheim Investigational Site; 🇺🇸 Indianapolis, Indiana, United States

511.133.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Cleveland, Ohio, United States

511.133.01032 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

511.133.01100 Boehringer Ingelheim Investigational Site; 🇺🇸 Wichita, Kansas, United States

511.133.01119 Boehringer Ingelheim Investigational Site; 🇺🇸 Fargo, North Dakota, United States

511.133.01058 Boehringer Ingelheim Investigational Site; 🇺🇸 Dayton, Ohio, United States

511.133.01063 Boehringer Ingelheim Investigational Site; 🇺🇸 Knoxville, Tennessee, United States

511.133.01052 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

511.133.01035 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

511.133.01099 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

511.133.01026 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

511.133.01033 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

511.133.01057 Boehringer Ingelheim Investigational Site; 🇺🇸 Las Vegas, Nevada, United States

511.133.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

511.133.01005 Boehringer Ingelheim Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

511.133.01141 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

511.133.01071 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

511.133.01060 Boehringer Ingelheim Investigational Site; 🇺🇸 Omaha, Nebraska, United States

511.133.01074 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

511.133.01025 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

511.133.01042 Boehringer Ingelheim Investigational Site; 🇺🇸 Mobile, Alabama, United States

511.133.01046 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntsville, Alabama, United States

511.133.01073 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

511.133.01127 Boehringer Ingelheim Investigational Site; 🇺🇸 Tuscon, Arizona, United States

511.133.01028 Boehringer Ingelheim Investigational Site; 🇺🇸 Fair Oaks, California, United States

511.133.01030 Boehringer Ingelheim Investigational Site; 🇺🇸 Encinitas, California, United States

511.133.01136 Boehringer Ingelheim Investigational Site; 🇺🇸 La Mesa, California, United States

511.133.01115 Boehringer Ingelheim Investigational Site; 🇺🇸 Oceanside, California, United States

511.133.01128 Boehringer Ingelheim Investigational Site; 🇺🇸 Newport Beach, California, United States

511.133.01016 Boehringer Ingelheim Investigational Site; 🇺🇸 Tarzana, California, United States

511.133.01021 Boehringer Ingelheim Investigational Site; 🇺🇸 Vista, California, United States

511.133.01051 Boehringer Ingelheim Investigational Site; 🇺🇸 Westlake Village, California, United States

511.133.01053 Boehringer Ingelheim Investigational Site; 🇺🇸 Farmington, Connecticut, United States

511.133.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 Groton, Connecticut, United States

511.133.01139 Boehringer Ingelheim Investigational Site; 🇺🇸 New London, Connecticut, United States

511.133.01065 Boehringer Ingelheim Investigational Site; 🇺🇸 Daytona Beach, Florida, United States

511.133.01062 Boehringer Ingelheim Investigational Site; 🇺🇸 Washington, District of Columbia, United States

511.133.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Boynton Beach, Florida, United States

511.133.01132 Boehringer Ingelheim Investigational Site; 🇺🇸 Coral Gables, Florida, United States

511.133.01056 Boehringer Ingelheim Investigational Site; 🇺🇸 Clearwater, Florida, United States

511.133.01070 Boehringer Ingelheim Investigational Site; 🇺🇸 Palm Harbor, Florida, United States

511.133.01019 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Petersburg, Florida, United States

511.133.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 West Palm Beach, Florida, United States

511.133.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 West Palm Beach, Florida, United States

511.133.01009 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

511.133.01023 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

511.133.01082 Boehringer Ingelheim Investigational Site; 🇺🇸 Marietta, Georgia, United States

511.133.01008 Boehringer Ingelheim Investigational Site; 🇺🇸 Sandy Springs, Georgia, United States

511.133.01044 Boehringer Ingelheim Investigational Site; 🇺🇸 Chicago, Illinois, United States

511.133.01067 Boehringer Ingelheim Investigational Site; 🇺🇸 Lafayette, Louisiana, United States

511.133.01013 Boehringer Ingelheim Investigational Site; 🇺🇸 Baltimore, Maryland, United States

511.133.01031 Boehringer Ingelheim Investigational Site; 🇺🇸 Bingham Farms, Michigan, United States

511.133.01014 Boehringer Ingelheim Investigational Site; 🇺🇸 Billings, Montana, United States

511.133.01039 Boehringer Ingelheim Investigational Site; 🇺🇸 Moorestown, New Jersey, United States

511.133.01017 Boehringer Ingelheim Investigational Site; 🇺🇸 Endwell, New York, United States

511.133.01135 Boehringer Ingelheim Investigational Site; 🇺🇸 Cary, North Carolina, United States

511.133.01047 Boehringer Ingelheim Investigational Site; 🇺🇸 New Bern, North Carolina, United States

511.133.01138 Boehringer Ingelheim Investigational Site; 🇺🇸 Winston Salem, North Carolina, United States

511.133.01072 Boehringer Ingelheim Investigational Site; 🇺🇸 Edmond, Oklahoma, United States

511.133.01105 Boehringer Ingelheim Investigational Site; 🇺🇸 Englewood, Ohio, United States

511.133.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 Eugene, Oregon, United States

511.133.01068 Boehringer Ingelheim Investigational Site; 🇺🇸 Mt Pleasant, South Carolina, United States

511.133.01084 Boehringer Ingelheim Investigational Site; 🇺🇸 Chattanooga, Tennessee, United States

511.133.01010 Boehringer Ingelheim Investigational Site; 🇺🇸 Nashville, Tennessee, United States

511.133.01036 Boehringer Ingelheim Investigational Site; 🇺🇸 Nashville, Tennessee, United States

511.133.01018 Boehringer Ingelheim Investigational Site; 🇺🇸 Corpus Christi, Texas, United States

511.133.01011 Boehringer Ingelheim Investigational Site; 🇺🇸 Katy, Texas, United States

511.133.01069 Boehringer Ingelheim Investigational Site; 🇺🇸 Sandy, Utah, United States

511.133.01049 Boehringer Ingelheim Investigational Site; 🇺🇸 Virgnia Beach, Virginia, United States

511.133.01045 Boehringer Ingelheim Investigational Site; 🇺🇸 Spokane, Washington, United States

511.133.02014 Boehringer Ingelheim Investigational Site; 🇨🇦 Victoria, British Columbia, Canada

511.133.02004 Boehringer Ingelheim Investigational Site; 🇨🇦 Calgary, Alberta, Canada

511.133.01038 Boehringer Ingelheim Investigational Site; 🇺🇸 Tacoma, Washington, United States

511.133.02005 Boehringer Ingelheim Investigational Site; 🇨🇦 Ottawa, Ontario, Canada

511.133.02006 Boehringer Ingelheim Investigational Site; 🇨🇦 Burlington, Ontario, Canada

511.133.02002 Boehringer Ingelheim Investigational Site; 🇨🇦 Quebec, Canada

511.133.02003 Boehringer Ingelheim Investigational Site; 🇨🇦 Saskatoon, Saskatchewan, Canada

511.133.01037 Boehringer Ingelheim Investigational Site; 🇺🇸 Irvine, California, United States

511.133.01022 Boehringer Ingelheim Investigational Site; 🇺🇸 Sacremento, California, United States

511.133.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Louis, Missouri, United States

511.133.01055 Boehringer Ingelheim Investigational Site; 🇺🇸 Pittsburgh, Pennsylvania, United States

511.133.01040 Boehringer Ingelheim Investigational Site; 🇺🇸 Norfolk, Virginia, United States

511.133.01054 Boehringer Ingelheim Investigational Site; 🇺🇸 Renton, Washington, United States

511.133.02016 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

511.133.01029 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States

511.133.01043 Boehringer Ingelheim Investigational Site; 🇺🇸 Orlando, Florida, United States

511.133.01075 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States

511.133.01061 Boehringer Ingelheim Investigational Site; 🇺🇸 Tampa, Florida, United States

511.133.01066 Boehringer Ingelheim Investigational Site; 🇺🇸 Tampa, Florida, United States

511.133.01027 Boehringer Ingelheim Investigational Site; 🇺🇸 Winston-Salem, North Carolina, United States