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This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flibanserin | Experimental | flibanserin 100 mg dose every evening |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flibanserin 100 mg dose every evening | Drug | all subjects receive flibanserin |
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| Measure | Description | Time Frame |
|---|---|---|
| Flibanserin: Area Under the Curve; AUC_0-∞ | Geometric mean of the AUC_0-∞ of Flibanserin | 8 days |
| Flibanserin: AUC τ,ss | Geometric mean of the AUC τ,ss of Flibanserin | 8 days |
| Flibanserin: Cmax (Peak Concentration) | Geometric mean of the Cmax of Flibanserin | 8 days |
| Flibanserin: Cmax,ss | Geometric mean of the Cmax,ss of Flibanserin | 8 days |
| Flibanserin: Tmax,ss | Median of the tmax,ss of Flibanserin | 8 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sprout Pharmaceuticals | Sprout Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 511.146.01003 Boehringer Ingelheim Investigational Site | Orlando | Florida | United States | |||
| 511.146.01005 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flibanserin | 100mg Flibanserin administered orally once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Wichita |
| Kansas |
| United States |
| 511.146.01001 Boehringer Ingelheim Investigational Site | Kalamazoo | Michigan | United States |
| 511.146.01004 Boehringer Ingelheim Investigational Site | Knoxville | Tennessee | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Flibanserin | 100mg Flibanserin administered orally once daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| 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 | Flibanserin: Area Under the Curve; AUC_0-∞ | Geometric mean of the AUC_0-∞ of Flibanserin | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 8 days |
|
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| Primary | Flibanserin: AUC τ,ss | Geometric mean of the AUC τ,ss of Flibanserin | All patients with values for the area under the concentration-time curve of the analyte in plasma over a dosing interval τ at steady state (AUC τ,ss) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 8 days |
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| Primary | Flibanserin: Cmax (Peak Concentration) | Geometric mean of the Cmax of Flibanserin | All patients with values for the maximum concentration of Flibanserin in plasma after single dose (Cmax) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 8 days |
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| Primary | Flibanserin: Cmax,ss | Geometric mean of the Cmax,ss of Flibanserin | All patients with values for the maximum concentration of Flibanserin in plasma after single dose at steady state (Cmax,ss) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 8 days |
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| Primary | Flibanserin: Tmax,ss | Median of the tmax,ss of Flibanserin | All patients with values for the time from dosing to the maximum measured concentration of flibanserin in plasma after single dose at steady state (tmax,ss) | Posted | Median | Full Range | h | 8 days |
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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 administered orally once daily | 0 | 24 | 13 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Sprout Pharmaceuticals publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sprout Pharmaceuticals | Sprout Pharmaceuticals | 1-919-882-0850 | 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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