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This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flibanserin 25 mg b.i.d | Experimental | 25 mg twice daily for 24 weeks |
|
| flibanserin 50mg qhs | Experimental | 50 mg taken once daily at bedtime for 24 weeks |
|
| flibanserin 50mg b.i.d. | Experimental | 50 mg twice daily for 24 weeks |
|
| placebo | Placebo Comparator | twice daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flibanserin | Drug | Experimental: flibanserin 25 mg b.i.d |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary. | A small personal handheld electronic device (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. | 24 weeks |
| Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question. | Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read "Indicate your most intense level of sexual desire in the last 24 hours / since your last visit." Potential responses included "no," "low," "moderate," or "strong" and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire: 0 = No desire
| 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 |
|---|---|---|---|---|---|---|
| 511.70.01068 Boehringer Ingelheim Investigational Site | Huntsville | Alabama | United States | |||
| 511.70.01040 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flibanserin 25 mg b.i.d | 25 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 25 mg b.i.d |
| FG001 | Flibanserin 50mg Qhs | 50 mg taken once daily at bedtime for 24 weeks flibanserin: Experimental: flibanserin 50mg qhs |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| flibanserin |
| Drug |
Experimental: flibanserin 50mg qhs |
|
| flibanserin | Drug | Experimental: flibanserin 50mg b.i.d. |
|
| placebo | Drug | placebo |
|
| Mobile |
| Alabama |
| United States |
| 511.70.01041 Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States |
| 511.70.01003 Boehringer Ingelheim Investigational Site | Jonesboro | Arkansas | United States |
| 511.70.01070 Boehringer Ingelheim Investigational Site | Carmichael | California | United States |
| 511.70.01026 Boehringer Ingelheim Investigational Site | Redding | California | United States |
| 511.70.01015 Boehringer Ingelheim Investigational Site | San Diego | California | United States |
| 511.70.01014 Boehringer Ingelheim Investigational Site | Stanford | California | United States |
| 511.70.01017 Boehringer Ingelheim Investigational Site | Tarzana | California | United States |
| 511.70.01072 Boehringer Ingelheim Investigational Site | Torrance | California | United States |
| 511.70.01078 Boehringer Ingelheim Investigational Site | Vista | California | United States |
| 511.70.01066 Boehringer Ingelheim Investigational Site | Walnut Creek | California | United States |
| 511.70.01064 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States |
| 511.70.01001 Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado | United States |
| 511.70.01050 Boehringer Ingelheim Investigational Site | Farmington | Connecticut | United States |
| 511.70.01006 Boehringer Ingelheim Investigational Site | Hartford | Connecticut | United States |
| 511.70.01055 Boehringer Ingelheim Investigational Site | New London | Connecticut | United States |
| 511.70.01024 Boehringer Ingelheim Investigational Site | Aventura | Florida | United States |
| 511.70.01056 Boehringer Ingelheim Investigational Site | Daytona Beach | Florida | United States |
| 511.70.01090 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | United States |
| 511.70.01027 Boehringer Ingelheim Investigational Site | Gainesville | Florida | United States |
| 511.70.01062 Boehringer Ingelheim Investigational Site | New Port Richey | Florida | United States |
| 511.70.01043 Boehringer Ingelheim Investigational Site | Orlando | Florida | United States |
| 511.70.01084 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States |
| 511.70.01048 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | United States |
| 511.70.01042 Boehringer Ingelheim Investigational Site | Stuart | Florida | United States |
| 511.70.01063 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States |
| 511.70.01085 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States |
| 511.70.01086 Boehringer Ingelheim Investigational Site | West Palm Beach | Florida | United States |
| 511.70.01022 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States |
| 511.70.01057 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States |
| 511.70.01087 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States |
| 511.70.01052 Boehringer Ingelheim Investigational Site | Roswell | Georgia | United States |
| 511.70.01060 Boehringer Ingelheim Investigational Site | Champaign | Illinois | United States |
| 511.70.01058 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 511.70.01032 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States |
| 511.70.01018 Boehringer Ingelheim Investigational Site | Lexington | Kentucky | United States |
| 511.70.01007 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | United States |
| 511.70.01047 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | United States |
| 511.70.01079 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | United States |
| 511.70.01031 Boehringer Ingelheim Investigational Site | Saint Louis | Maryland | United States |
| 511.70.01011 Boehringer Ingelheim Investigational Site | Haverhill | Massachusetts | United States |
| 511.70.01028 Boehringer Ingelheim Investigational Site | Detroit | Michigan | United States |
| 511.70.01081 Boehringer Ingelheim Investigational Site | Detroit | Michigan | United States |
| 511.70.01082 Boehringer Ingelheim Investigational Site | Billings | Montana | United States |
| 511.70.01077 Boehringer Ingelheim Investigational Site | Moorestown | New Jersey | United States |
| 511.70.01019 Boehringer Ingelheim Investigational Site | Endwell | New York | United States |
| 511.70.01076 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 511.70.01025 Boehringer Ingelheim Investigational Site | Poughkeepsie | New York | United States |
| 511.70.01067 Boehringer Ingelheim Investigational Site | Purchase | New York | United States |
| 511.70.01016 Boehringer Ingelheim Investigational Site | Mount Airy | North Carolina | United States |
| 511.70.01044 Boehringer Ingelheim Investigational Site | Raleigh | North Carolina | United States |
| 511.70.01049 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States |
| 511.70.01089 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States |
| 511.70.01054 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States |
| 511.70.01075 Boehringer Ingelheim Investigational Site | Dayton | Ohio | United States |
| 511.70.01002 Boehringer Ingelheim Investigational Site | Mayfield Heights | Ohio | United States |
| 511.70.01065 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | United States |
| 511.70.01083 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | United States |
| 511.70.01036 Boehringer Ingelheim Investigational Site | Medford | Oregon | United States |
| 511.70.01004 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 511.70.01021 Boehringer Ingelheim Investigational Site | West Reading | Pennsylvania | United States |
| 511.70.01073 Boehringer Ingelheim Investigational Site | Warwick | Rhode Island | United States |
| 511.70.01023 Boehringer Ingelheim Investigational Site | Anderson | South Carolina | United States |
| 511.70.01035 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| 511.70.01008 Boehringer Ingelheim Investigational Site | Nasville | Tennessee | United States |
| 511.70.01020 Boehringer Ingelheim Investigational Site | Corpus Christi | Texas | United States |
| 511.70.01009 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 511.70.01030 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 511.70.01091 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 511.70.01013 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| 511.70.01005 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States |
| 511.70.01061 Boehringer Ingelheim Investigational Site | Sandy City | Utah | United States |
| 511.70.01010 Boehringer Ingelheim Investigational Site | Burlington | Vermont | United States |
| 511.70.01012 Boehringer Ingelheim Investigational Site | Charlottesville | Virginia | United States |
| 511.70.01046 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States |
| 511.70.01029 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States |
| 511.70.01071 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States |
| 511.70.01033 Boehringer Ingelheim Investigational Site | Bellevue | Washington | United States |
| 511.70.01039 Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States |
| 511.70.01069 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin | United States |
| FG002 | Flibanserin 50mg b.i.d. | 50 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 50mg b.i.d. |
| FG003 | Placebo | twice daily for 24 weeks placebo: placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flibanserin 25 mg b.i.d | 25 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 25 mg b.i.d |
| BG001 | Flibanserin 50mg Qhs | 50 mg taken once daily at bedtime for 24 weeks flibanserin: Experimental: flibanserin 50mg qhs |
| BG002 | Flibanserin 50mg b.i.d. | 50 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 50mg b.i.d. |
| BG003 | Placebo | twice daily for 24 weeks placebo: placebo |
| BG004 | 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 | Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary. | A small personal handheld electronic device (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. | The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy. | Posted | Mean | Standard Deviation | SSEs per week | 24 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question. | Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read "Indicate your most intense level of sexual desire in the last 24 hours / since your last visit." Potential responses included "no," "low," "moderate," or "strong" and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire: 0 = No 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, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy. | Posted | Least Squares Mean | Standard Error | units on a scale | 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 25 mg b.i.d | 25 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 25 mg b.i.d | 1 | 337 | 107 | 337 | ||
| EG001 | Flibanserin 50mg Qhs | 50 mg taken once daily at bedtime for 24 weeks flibanserin: Experimental: flibanserin 50mg qhs | 3 | 363 | 126 | 363 | ||
| EG002 | Flibanserin 50mg b.i.d. | 50 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 50mg b.i.d. | 1 | 336 | 243 | 336 | ||
| EG003 | Placebo | twice daily for 24 weeks placebo: placebo | 1 | 349 | 78 | 349 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema infectiosum | Infections and infestations | Systematic Assessment |
| ||
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Breast Cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Fatigue | Nervous system disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krista Barbour, Ph.D. | Sprout Pharmaceuticals | 9198820850 | kbarbour@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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| 35-44 years |
|
| 45 years and older |
|
| Male |
|
| White Hispanic |
|
| Black Non Hispanic |
|
| Black Hispanic |
|
| Asian Non Hispanic |
|
| Asian Hispanic |
|
| Missing |
|
50 mg taken once daily at bedtime for 24 weeks
flibanserin: Experimental: flibanserin 50mg qhs
| OG002 | Flibanserin 50mg b.i.d. | 50 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 50mg b.i.d. |
| OG003 | Placebo | twice daily for 24 weeks placebo: placebo |
|
|