Sexual Dysfunctions, Psychological
Conditions
Brief summary
This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder.
Interventions
DRUGflibanserin 100 mg dose every evening
all subjects receive flibanserin
Sponsors
Sprout Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
1. Patients must be in a stable, monogamous heterosexual relationship for at least one year. 2. Patients must have a primary diagnosis of Hypoactive Sexual Desire Disorder for at least six months. 3. Patients must be naturally postmenopausal women of any age with at least one ovary. 4. Patients may participate whether or not they are currently taking systemic hormone therapy provided the therapy was not prescribed for treatment of low sexual desire. Hormone therapy must be at a stable dose for at least six months.
Exclusion criteria
1. Patients with a history of drug dependence or abuse within the past twelve months. 2. Patients who have been previously treated with flibanserin. 3. Patients who have sexual dysfunctions other than Hypoactive Sexual Desire Disorder, such as: Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder,Paraphilia, or Sexual Dysfunction due to a general medical condition. 4. Patients who indicate that their sexual partner has inadequately treated organic or psychosexual dysfunction that could interfere with a patients response to treatment. 5. Patients whose sexual function was impaired, in the investigators opinion, by abdominal or vaginal hysterectomy, oophorectomy or any other pelvic, vaginal, or urologic surgery. 6. Patients with pelvic pain, pelvic inflammatory disease, endometriosis, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, symptomatic vaginal atrophy or any other gynecological pathology requiring further evaluation. 7. Patients with a history of unexplained vaginal bleeding within the past twelve months. 8. Patients with a history of Major Depressive Disorder within six months prior to Screening; ; active suicidal ideation with intent in the past ten years or suicidal behavior at any time. 9. Patients with a history of any other psychiatric disorder that could impact sexual function, increase risks to patient safety, or impair patient compliance. Such disorders include but are not limited to bipolar disorder, psychotic disorders, severe anxiety, eating disorders, and antisocial personality disorders. 10. Clinically significant electrocardiogram abnormalities at Screening. 11. Patients with a history of dementia or other neurodegenerative disease; organic brain disease; stroke; transient ischemic attacks; multiple sclerosis; spinal cord injury; brain surgery; significant brain trauma; peripheral neuropathy; and epilepsy. 12. Patients with ongoing hepatic impairment (cirrhosis, hepatic tumor, or other hepatic disease); peptic ulcer within six months prior to Screening; elevated liver enzymes ; inflammatory bowel disease; gastrointestinal bleeding within two months prior to Screening; Patients who have had bariatric surgery for obesity. 13. Patients with a history of angina; atherosclerotic cardiovascular disease; congestive heart failure; cardiomyopathy; symptomatic cardiac valve disease; arrhythmia; hypertension. 14. Patients with a history of renal failure; known history of chronic glomerulonephritis. 15. Patients with a history of chronic obstructive pulmonary disease, chronic bronchitis, or asthma not well controlled with medication taken twice daily or less. 16. Patients with a history of gonadotrophic hormone disorders or uncontrolled diabetes mellitus. 17. Uncorrected hypothyroidism or hyperthyroidism. 18. Patients with a history of uncontrolled glaucoma. 19. Patients with known Human Immunodeficiency Virus infection, Acquired Immunodeficiency Syndrome, other clinically significant immunological disorders or auto-immune disorders such as lupus or scleroderma. 20. Patients with a history of any cancer within the past ten years, other than non-invasive, previously resected basal cell carcinoma of the skin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flibanserin: Area Under the Curve; AUC_0-∞ | 8 days | Geometric mean of the AUC\_0-∞ of Flibanserin |
| Flibanserin: AUC τ,ss | 8 days | Geometric mean of the AUC τ,ss of Flibanserin |
| Flibanserin: Cmax (Peak Concentration) | 8 days | Geometric mean of the Cmax of Flibanserin |
| Flibanserin: Cmax,ss | 8 days | Geometric mean of the Cmax,ss of Flibanserin |
| Flibanserin: Tmax,ss | 8 days | Median of the tmax,ss of Flibanserin |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flibanserin 100mg Flibanserin administered orally once daily | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Flibanserin |
|---|---|
| Age, Continuous | 59.6 Years STANDARD_DEVIATION 8.3 |
| BMI | 28.25 kg/m^2 STANDARD_DEVIATION 5.31 |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Flibanserin: Area Under the Curve; AUC_0-∞
Geometric mean of the AUC\_0-∞ of Flibanserin
Time frame: 8 days
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin | Flibanserin: Area Under the Curve; AUC_0-∞ | 2570 ng*h/mL | Geometric Coefficient of Variation 73 |
Primary
Flibanserin: AUC τ,ss
Geometric mean of the AUC τ,ss of Flibanserin
Time frame: 8 days
Population: 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)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin | Flibanserin: AUC τ,ss | 3000 ng*h/mL | Geometric Coefficient of Variation 60.9 |
Primary
Flibanserin: Cmax (Peak Concentration)
Geometric mean of the Cmax of Flibanserin
Time frame: 8 days
Population: All patients with values for the maximum concentration of Flibanserin in plasma after single dose (Cmax)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin | Flibanserin: Cmax (Peak Concentration) | 298 ng/mL | Geometric Coefficient of Variation 56.4 |
Primary
Flibanserin: Cmax,ss
Geometric mean of the Cmax,ss of Flibanserin
Time frame: 8 days
Population: All patients with values for the maximum concentration of Flibanserin in plasma after single dose at steady state (Cmax,ss)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin | Flibanserin: Cmax,ss | 406 ng/mL | Geometric Coefficient of Variation 60.7 |
Primary
Flibanserin: Tmax,ss
Median of the tmax,ss of Flibanserin
Time frame: 8 days
Population: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Flibanserin | Flibanserin: Tmax,ss | 1.50 h |