MedPath

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

Phase 3
Completed
Conditions
Sexual Dysfunctions, Psychological
Interventions
Drug: flibanserin
Drug: placebo
Registration Number
NCT00996372
Lead Sponsor
Sprout Pharmaceuticals, Inc
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
949
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
GroupInterventionDescription
flibanserin 100mgflibanserinflibanserin 100mg po qd
placeboplaceboplacebo one tablet po qd
Primary Outcome Measures
NameTimeMethod
Change From Baseline in the Number of Satisfying Sexual Eventsbaseline through 24 weeks

A small handheld electronic device (eDiary) was used by 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 could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.

Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domainbaseline through 24 weeks

The FSFI© is a brief, self-administered questionnaire to assess key dimensions 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 (with 1 being the lowest report of desire and 5 being the highest). 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 to 6.0 (the higher the score, the higher the reported level of desire).

Secondary Outcome Measures
NameTimeMethod
Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R)change from baseline to 24 weeks

The FSDS© is a self-administered measure of female personal distress associated with sexual dysfunction. Question 13 inquires about distress specifically related to sexual desire. The range for each question, including Question 13, is 0 (Never) to 4 (Always).

Trial Locations

Locations (75)

511.130.01041 Boehringer Ingelheim Investigational Site

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New Britain, Connecticut, United States

511.130.01009 Boehringer Ingelheim Investigational Site

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Atlanta, Georgia, United States

511.130.01013 Boehringer Ingelheim Investigational Site

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Baltimore, Maryland, United States

511.130.01004 Boehringer Ingelheim Investigational Site

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Cleveland, Ohio, United States

511.130.01032 Boehringer Ingelheim Investigational Site

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Houston, Texas, United States

511.130.01052 Boehringer Ingelheim Investigational Site

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San Diego, California, United States

511.130.01035 Boehringer Ingelheim Investigational Site

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San Diego, California, United States

511.130.01074 Boehringer Ingelheim Investigational Site

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Birmingham, Alabama, United States

511.130.01025 Boehringer Ingelheim Investigational Site

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Phoenix, Arizona, United States

511.130.01073 Boehringer Ingelheim Investigational Site

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Phoenix, Arizona, United States

511.130.01036 Boehringer Ingelheim Investigational Site

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Nashville, Tennessee, United States

511.130.01026 Boehringer Ingelheim Investigational Site

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San Antonio, Texas, United States

511.130.01005 Boehringer Ingelheim Investigational Site

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Salt Lake City, Utah, United States

511.130.01072 Boehringer Ingelheim Investigational Site

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Oklahoma City, Oklahoma, United States

511.130.01010 Boehringer Ingelheim Investigational Site

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Nashville, Tennessee, United States

511.130.01071 Boehringer Ingelheim Investigational Site

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Denver, Colorado, United States

511.130.01060 Boehringer Ingelheim Investigational Site

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Omaha, Nebraska, United States

511.130.01061 Boehringer Ingelheim Investigational Site

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Tampa, Florida, United States

511.130.01066 Boehringer Ingelheim Investigational Site

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Tampa, Florida, United States

511.130.01067 Boehringer Ingelheim Investigational Site

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Lafayette, Louisiana, United States

511.130.01056 Boehringer Ingelheim Investigational Site

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Clearwater, Florida, United States

511.130.01020 Boehringer Ingelheim Investigational Site

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Miami, Florida, United States

511.130.01042 Boehringer Ingelheim Investigational Site

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Mobile, Alabama, United States

511.130.01046 Boehringer Ingelheim Investigational Site

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Huntsville, Alabama, United States

511.130.01015 Boehringer Ingelheim Investigational Site

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Groton, Connecticut, United States

511.130.01062 Boehringer Ingelheim Investigational Site

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Washington, District of Columbia, United States

511.130.01024 Boehringer Ingelheim Investigational Site

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Miami, Florida, United States

511.130.01039 Boehringer Ingelheim Investigational Site

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Moorestown, New Jersey, United States

511.130.01031 Boehringer Ingelheim Investigational Site

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Bingham Farms, Michigan, United States

511.130.01006 Boehringer Ingelheim Investigational Site

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St. Louis, Missouri, United States

511.130.01057 Boehringer Ingelheim Investigational Site

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Las Vegas, Nevada, United States

511.130.01014 Boehringer Ingelheim Investigational Site

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Billings, Montana, United States

511.130.01058 Boehringer Ingelheim Investigational Site

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Dayton, Ohio, United States

511.130.01048 Boehringer Ingelheim Investigational Site

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Columbia, South Carolina, United States

511.130.01069 Boehringer Ingelheim Investigational Site

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Sandy, Utah, United States

511.130.01018 Boehringer Ingelheim Investigational Site

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Corpus Christi, Texas, United States

511.130.01003 Boehringer Ingelheim Investigational Site

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Boynton Beach, Florida, United States

511.130.01033 Boehringer Ingelheim Investigational Site

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Cincinnati, Ohio, United States

511.130.01012 Boehringer Ingelheim Investigational Site

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Mayfield Heights, Ohio, United States

511.130.01028 Boehringer Ingelheim Investigational Site

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Fair Oaks, California, United States

511.130.01021 Boehringer Ingelheim Investigational Site

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Vista, California, United States

511.130.01051 Boehringer Ingelheim Investigational Site

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Westlake Village, California, United States

511.130.01016 Boehringer Ingelheim Investigational Site

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Torrance, California, United States

511.130.01053 Boehringer Ingelheim Investigational Site

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Farmington, Connecticut, United States

511.130.01064 Boehringer Ingelheim Investigational Site

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Newark, Delaware, United States

511.130.01065 Boehringer Ingelheim Investigational Site

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Daytona Beach, Florida, United States

511.130.01070 Boehringer Ingelheim Investigational Site

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New Port Richey, Florida, United States

511.130.01019 Boehringer Ingelheim Investigational Site

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St. Petersburg, Florida, United States

511.130.01002 Boehringer Ingelheim Investigational Site

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West Palm Beach, Florida, United States

511.130.01044 Boehringer Ingelheim Investigational Site

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Chicago, Illinois, United States

511.130.01034 Boehringer Ingelheim Investigational Site

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Indianapolis, Indiana, United States

511.130.01050 Boehringer Ingelheim Investigational Site

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Columbus, Ohio, United States

511.130.01059 Boehringer Ingelheim Investigational Site

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Columbus, Ohio, United States

511.130.01063 Boehringer Ingelheim Investigational Site

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Knoxville, Tennessee, United States

511.130.01068 Boehringer Ingelheim Investigational Site

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Mt. Pleasant, South Carolina, United States

511.130.01011 Boehringer Ingelheim Investigational Site

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Katy, Texas, United States

511.130.01038 Boehringer Ingelheim Investigational Site

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Tacoma, Washington, United States

511.130.01047 Boehringer Ingelheim Investigational Site

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New Bern, North Carolina, United States

511.130.01049 Boehringer Ingelheim Investigational Site

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Norfolk, Virginia, United States

511.130.01001 Boehringer Ingelheim Investigational Site

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West Palm Beach, Florida, United States

511.130.01007 Boehringer Ingelheim Investigational Site

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Eugene, Oregon, United States

511.130.01030 Boehringer Ingelheim Investigational Site

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Encinitas, California, United States

511.130.01037 Boehringer Ingelheim Investigational Site

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Irvine, California, United States

511.130.01023 Boehringer Ingelheim Investigational Site

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Atlanta, Georgia, United States

511.130.01055 Boehringer Ingelheim Investigational Site

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Pittsburgh, Pennsylvania, United States

511.130.01008 Boehringer Ingelheim Investigational Site

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Sandy Springs, Georgia, United States

511.130.01017 Boehringer Ingelheim Investigational Site

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Endwell, New York, United States

511.130.01045 Boehringer Ingelheim Investigational Site

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Spokane, Washington, United States

511.130.01040 Boehringer Ingelheim Investigational Site

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Norfolk, Virginia, United States

511.130.01054 Boehringer Ingelheim Investigational Site

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Renton, Washington, United States

511.130.01022 Boehringer Ingelheim Investigational Site

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Sacramento, California, United States

511.130.01043 Boehringer Ingelheim Investigational Site

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Orlando, Florida, United States

511.130.01027 Boehringer Ingelheim Investigational Site

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Winston-Salem, North Carolina, United States

511.130.01029 Boehringer Ingelheim Investigational Site

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Richmond, Virginia, United States

511.130.01075 Boehringer Ingelheim Investigational Site

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Richmond, Virginia, United States

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