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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flibanserin 100mg | Experimental | flibanserin 100mg po qd |
|
| placebo | Placebo Comparator | placebo one tablet po qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flibanserin | Drug | patients will be randomized to flibanserin or placebo in a double-blind manner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Satisfying Sexual Events | 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. | baseline through 24 weeks |
| Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain | 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). | baseline through 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) | 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). | change from baseline to 24 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 511.130.01074 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |||
| 511.130.01046 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24281236 | Derived | Simon JA, Kingsberg SA, Shumel B, Hanes V, Garcia M Jr, Sand M. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause. 2014 Jun;21(6):633-40. doi: 10.1097/GME.0000000000000134. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flibanserin 100mg | flibanserin 100mg po qd flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner |
| FG001 | Placebo | placebo one tablet po qd placebo : patients will be randomized to flibanserin or placebo in a double-blind manner |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | patients will be randomized to flibanserin or placebo in a double-blind manner |
|
| Huntsville |
| Alabama |
| United States |
| 511.130.01042 Boehringer Ingelheim Investigational Site | Mobile | Alabama | United States |
| 511.130.01025 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States |
| 511.130.01073 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States |
| 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 |
| 511.130.01071 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States |
| 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 |
| 511.130.01064 Boehringer Ingelheim Investigational Site | Newark | Delaware | United States |
| 511.130.01062 Boehringer Ingelheim Investigational Site | Washington D.C. | District of Columbia | United States |
| 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 |
| 511.130.01020 Boehringer Ingelheim Investigational Site | Miami | Florida | United States |
| 511.130.01024 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 |
| 511.130.01001 Boehringer Ingelheim Investigational Site | West Palm Beach | Florida | United States |
| 511.130.01002 Boehringer Ingelheim Investigational Site | West Palm Beach | Florida | United States |
| 511.130.01009 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States |
| 511.130.01023 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States |
| 511.130.01008 Boehringer Ingelheim Investigational Site | Sandy Springs | Georgia | United States |
| 511.130.01044 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 511.130.01034 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States |
| 511.130.01067 Boehringer Ingelheim Investigational Site | Lafayette | Louisiana | United States |
| 511.130.01013 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States |
| 511.130.01031 Boehringer Ingelheim Investigational Site | Bingham Farms | Michigan | United States |
| 511.130.01006 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 511.130.01014 Boehringer Ingelheim Investigational Site | Billings | Montana | United States |
| 511.130.01060 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States |
| 511.130.01057 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | United States |
| 511.130.01039 Boehringer Ingelheim Investigational Site | Moorestown | New Jersey | United States |
| 511.130.01017 Boehringer Ingelheim Investigational Site | Endwell | New York | United States |
| 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 |
| 511.130.01033 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States |
| 511.130.01004 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | United States |
| 511.130.01050 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States |
| 511.130.01059 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 |
| 511.130.01072 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | United States |
| 511.130.01007 Boehringer Ingelheim Investigational Site | Eugene | Oregon | United States |
| 511.130.01055 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States |
| 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 |
| 511.130.01063 Boehringer Ingelheim Investigational Site | Knoxville | Tennessee | United States |
| 511.130.01010 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States |
| 511.130.01036 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States |
| 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 |
| 511.130.01005 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States |
| 511.130.01069 Boehringer Ingelheim Investigational Site | Sandy City | Utah | United States |
| 511.130.01040 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States |
| 511.130.01049 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States |
| 511.130.01029 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States |
| 511.130.01075 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flibanserin | |
| BG001 | Placebo | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Number of Satisfying Sexual Events | 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. | The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy. | Posted | Mean | Standard Deviation | sexual events | baseline through 24 weeks |
|
|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain | 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). | The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy. | Posted | Mean | Standard Deviation | units on a scale | baseline through 24 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) | 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). | The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy. | Posted | Least Squares Mean | Standard Error | units on a scale | change from baseline to 24 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flibanserin 100mg | flibanserin 100mg po qd flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner | 8 | 468 | 150 | 468 | ||
| EG001 | Placebo | placebo one tablet po qd placebo : patients will be randomized to flibanserin or placebo in a double-blind manner | 4 | 481 | 62 | 481 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| wrist fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| dengue fever | Infections and infestations | Systematic Assessment |
| ||
| chronic lymphocytic leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| intraventricular hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| duodenitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| hematemesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| hepatic enzyme increased | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Nervous system disorders | Systematic Assessment |
| ||
| somnolence | Nervous system disorders | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Development | Sprout Pharmaceuticals | 9198820850 | clinicaltrials@sproutpharma.com |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C098107 | flibanserin |
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| Title | Measurements |
|---|---|
|
| 55-64 |
|
| 65 years and older |
|
| Male |
|
| White Hispanic |
|
| Black/African American |
|
| Black/African American Hispanic |
|
| Asian |
|
| Asian Hispanic |
|
| American Indian/Alaskan Native |
|
| Hawaiian/Pacific Islander |
|
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|
|
|