Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
This study has been completed.
Sponsor:
Sprout Pharmaceuticals, Inc
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00996372
First received: October 15, 2009
Last updated: March 2, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sexual Dysfunctions, Psychological |
Drug: flibanserin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 24-wk Efficacy and Safety of Flibanserin vs Pbo in Naturally Postmenopausal Women in United States |
Resource links provided by NLM:
Further study details as provided by Sprout Pharmaceuticals, Inc:
Primary Outcome Measures:
- Change from baseline in the number of satisfying sexual events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in the score on the Female Sexual Function Index (FSFI) desire domain [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline on FSDS R total score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline on FSFI total score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Score on Patient Global Impression of Improvement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 949 |
| Study Start Date: | October 2009 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: flibanserin 100mg
flibanserin 100mg po qd
|
Drug: flibanserin
patients will be randomized to flibanserin or placebo in a double-blind manner
Drug: placebo
patients will be randomized to flibanserin or placebo in a double-blind manner
|
|
Placebo Comparator: placebo
placebo one tablet po qd
|
Drug: placebo
patients will be randomized to flibanserin or placebo in a double-blind manner
|
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996372
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| United States, Alabama | |
| 511.130.01074 Boehringer Ingelheim Investigational Site | |
| Birmingham, Alabama, United States | |
| 511.130.01046 Boehringer Ingelheim Investigational Site | |
| Huntsville, Alabama, United States | |
| 511.130.01042 Boehringer Ingelheim Investigational Site | |
| Mobile, Alabama, United States | |
| United States, Arizona | |
| 511.130.01073 Boehringer Ingelheim Investigational Site | |
| Phoenix, Arizona, United States | |
| 511.130.01025 Boehringer Ingelheim Investigational Site | |
| Phoenix, Arizona, United States | |
| United States, California | |
| 511.130.01030 Boehringer Ingelheim Investigational Site | |
| Encinitas, California, United States | |
| 511.130.01028 Boehringer Ingelheim Investigational Site | |
| Fair Oaks, California, United States | |
| 511.130.01037 Boehringer Ingelheim Investigational Site | |
| Irvine, California, United States | |
| 511.130.01022 Boehringer Ingelheim Investigational Site | |
| Sacramento, California, United States | |
| 511.130.01035 Boehringer Ingelheim Investigational Site | |
| San Diego, California, United States | |
| 511.130.01052 Boehringer Ingelheim Investigational Site | |
| San Diego, California, United States | |
| 511.130.01016 Boehringer Ingelheim Investigational Site | |
| Torrance, California, United States | |
| 511.130.01021 Boehringer Ingelheim Investigational Site | |
| Vista, California, United States | |
| 511.130.01051 Boehringer Ingelheim Investigational Site | |
| Westlake Village, California, United States | |
| United States, Colorado | |
| 511.130.01071 Boehringer Ingelheim Investigational Site | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| 511.130.01053 Boehringer Ingelheim Investigational Site | |
| Farmington, Connecticut, United States | |
| 511.130.01015 Boehringer Ingelheim Investigational Site | |
| Groton, Connecticut, United States | |
| 511.130.01041 Boehringer Ingelheim Investigational Site | |
| New Britain, Connecticut, United States | |
| United States, Delaware | |
| 511.130.01064 Boehringer Ingelheim Investigational Site | |
| Newark, Delaware, United States | |
| United States, District of Columbia | |
| 511.130.01062 Boehringer Ingelheim Investigational Site | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| 511.130.01003 Boehringer Ingelheim Investigational Site | |
| Boynton Beach, Florida, United States | |
| 511.130.01056 Boehringer Ingelheim Investigational Site | |
| Clearwater, Florida, United States | |
| 511.130.01065 Boehringer Ingelheim Investigational Site | |
| Daytona Beach, Florida, United States | |
| 511.130.01024 Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| 511.130.01020 Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| 511.130.01070 Boehringer Ingelheim Investigational Site | |
| New Port Richey, Florida, United States | |
| 511.130.01043 Boehringer Ingelheim Investigational Site | |
| Orlando, Florida, United States | |
| 511.130.01019 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Florida, United States | |
| 511.130.01061 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| 511.130.01066 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| 511.130.01002 Boehringer Ingelheim Investigational Site | |
| West Palm Beach, Florida, United States | |
| 511.130.01001 Boehringer Ingelheim Investigational Site | |
| West Palm Beach, Florida, United States | |
| United States, Georgia | |
| 511.130.01023 Boehringer Ingelheim Investigational Site | |
| Atlanta, Georgia, United States | |
| 511.130.01009 Boehringer Ingelheim Investigational Site | |
| Atlanta, Georgia, United States | |
| 511.130.01008 Boehringer Ingelheim Investigational Site | |
| Sandy Springs, Georgia, United States | |
| United States, Illinois | |
| 511.130.01044 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| 511.130.01034 Boehringer Ingelheim Investigational Site | |
| Indianapolis, Indiana, United States | |
| United States, Louisiana | |
| 511.130.01067 Boehringer Ingelheim Investigational Site | |
| Lafayette, Louisiana, United States | |
| United States, Maryland | |
| 511.130.01013 Boehringer Ingelheim Investigational Site | |
| Baltimore, Maryland, United States | |
| United States, Michigan | |
| 511.130.01031 Boehringer Ingelheim Investigational Site | |
| Bingham Farms, Michigan, United States | |
| United States, Missouri | |
| 511.130.01006 Boehringer Ingelheim Investigational Site | |
| St. Louis, Missouri, United States | |
| United States, Montana | |
| 511.130.01014 Boehringer Ingelheim Investigational Site | |
| Billings, Montana, United States | |
| United States, Nebraska | |
| 511.130.01060 Boehringer Ingelheim Investigational Site | |
| Omaha, Nebraska, United States | |
| United States, Nevada | |
| 511.130.01057 Boehringer Ingelheim Investigational Site | |
| Las Vegas, Nevada, United States | |
| United States, New Jersey | |
| 511.130.01039 Boehringer Ingelheim Investigational Site | |
| Moorestown, New Jersey, United States | |
| United States, New York | |
| 511.130.01017 Boehringer Ingelheim Investigational Site | |
| Endwell, New York, United States | |
| United States, North Carolina | |
| 511.130.01047 Boehringer Ingelheim Investigational Site | |
| New Bern, North Carolina, United States | |
| 511.130.01027 Boehringer Ingelheim Investigational Site | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| 511.130.01033 Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| 511.130.01004 Boehringer Ingelheim Investigational Site | |
| Cleveland, Ohio, United States | |
| 511.130.01059 Boehringer Ingelheim Investigational Site | |
| Columbus, Ohio, United States | |
| 511.130.01050 Boehringer Ingelheim Investigational Site | |
| Columbus, Ohio, United States | |
| 511.130.01058 Boehringer Ingelheim Investigational Site | |
| Dayton, Ohio, United States | |
| 511.130.01012 Boehringer Ingelheim Investigational Site | |
| Mayfield Heights, Ohio, United States | |
| United States, Oklahoma | |
| 511.130.01072 Boehringer Ingelheim Investigational Site | |
| Oklahoma City, Oklahoma, United States | |
| United States, Oregon | |
| 511.130.01007 Boehringer Ingelheim Investigational Site | |
| Eugene, Oregon, United States | |
| United States, Pennsylvania | |
| 511.130.01055 Boehringer Ingelheim Investigational Site | |
| Pittsburgh, Pennsylvania, United States | |
| United States, South Carolina | |
| 511.130.01048 Boehringer Ingelheim Investigational Site | |
| Columbia, South Carolina, United States | |
| 511.130.01068 Boehringer Ingelheim Investigational Site | |
| Mt. Pleasant, South Carolina, United States | |
| United States, Tennessee | |
| 511.130.01063 Boehringer Ingelheim Investigational Site | |
| Knoxville, Tennessee, United States | |
| 511.130.01036 Boehringer Ingelheim Investigational Site | |
| Nashville, Tennessee, United States | |
| 511.130.01010 Boehringer Ingelheim Investigational Site | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| 511.130.01018 Boehringer Ingelheim Investigational Site | |
| Corpus Christi, Texas, United States | |
| 511.130.01032 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| 511.130.01011 Boehringer Ingelheim Investigational Site | |
| Katy, Texas, United States | |
| 511.130.01026 Boehringer Ingelheim Investigational Site | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| 511.130.01005 Boehringer Ingelheim Investigational Site | |
| Salt Lake City, Utah, United States | |
| 511.130.01069 Boehringer Ingelheim Investigational Site | |
| Sandy, Utah, United States | |
| United States, Virginia | |
| 511.130.01049 Boehringer Ingelheim Investigational Site | |
| Norfolk, Virginia, United States | |
| 511.130.01040 Boehringer Ingelheim Investigational Site | |
| Norfolk, Virginia, United States | |
| 511.130.01075 Boehringer Ingelheim Investigational Site | |
| Richmond, Virginia, United States | |
| 511.130.01029 Boehringer Ingelheim Investigational Site | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| 511.130.01054 Boehringer Ingelheim Investigational Site | |
| Renton, Washington, United States | |
| 511.130.01045 Boehringer Ingelheim Investigational Site | |
| Spokane, Washington, United States | |
| 511.130.01038 Boehringer Ingelheim Investigational Site | |
| Tacoma, Washington, United States | |
Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Sprout Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00996372 History of Changes |
| Other Study ID Numbers: | 511.130 |
| Study First Received: | October 15, 2009 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 13, 2013