Depression, Sexual Dysfunctions, Psychological
Conditions
Brief summary
The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.
Interventions
DRUGflibanserin 50 mg to 100 mg qhs
50 to 100mg qhs
DRUGflibanserin 100 mg qhs
100mg qhs
DRUGplacebo 2 tablets qhs
50 mg placebo
Sponsors
Sprout Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Women 18-50 years of age, not postmenopausal at the Screen Visit 2. Women with mild/remitted depressive disorder with score of \<11 on the Quick Inventory of Depressive Symptoms Self Report and \<16 on the Beck Anxiety Inventory at Screen/Baseline Visits 3. Women with decreased sexual desire and distress present at least 4 weeks at Screen Visit as determined by the Clinical Interview for Female Sexual Dysfunction-Depression and Diagnostic and Statistical Manual IV-Text Revision (DSM IV-TR) 4. Score of 15 or higher on the Female Sexual Distress Scale-Revised at Screen/Baseline Visits 5. Score of 9 or lower on the Changes in Sexual Functioning Questionnaire-Female desire/interest item at Screen/Baseline Visits 6. Patients must be taking the same Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor for 3 months and be on a stable dose at least 2 months before the Screen Visit and remain on this regimen during the trial and for 1 month after trial completion 7. Patients must have had no treatment for Female Sexual Dysfunction 2 months before Screen Visit 8. Patients must use medically accepted contraception method 9. Patients must be in a secure, stable, monogamous, heterosexual relationship at least 12 months prior to Screen Visit, according to the Clinical Interview for Female Sexual Dysfunction-Depression
Exclusion criteria
Conditions which may interfere with the ability to participate include, but are not limited to: 1. Patients who have taken any Prohibited Medications within 30 days before Baseline Visit 2. Patients with history of drug dependence/abuse (including alcohol) within past year 3. Patients with history of participation in a trial of another investigational drug within 1 month prior to the Screen Visit, or participation in previous flibanserin study 4. Women with lifelong decreased sexual desire (or Hypoactive Sexual Desire Disorder), Female Sexual Arousal Disorder and/or Female Orgasmic Disorder, per DSM IV-TR criteria 5. Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction other than Selective Serotonin Reuptake Inhibitor/Norepinephrine Serotonin Reuptake Inhibitor-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia, or Sexual Dysfunction Due to a General Medical Condition 6. Patients who have had a hysterectomy, or are in the post menopause stage (i.e., bilateral oophorectomy, chemically induced menopause) 7. Patients with history of pelvic inflammatory disease, urinary tract, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, significant vaginal atrophy in the 4 weeks before the Screen Visit 8. Patients who are breastfeeding or have breastfed within 6 months prior to the Baseline Visit. 9. Patients who are pregnant (by serum pregnancy test) or have been pregnant within 6 months prior to the Baseline Visit 10. Patients with current Depressive Disorder (may have concurrent mild Anxiety Disorder) not adequately controlled during the last 2 months and/or with a score of \<11 on the Quick Inventory of Depressive Symptoms Self Report and/or a score of \<16 on the Beck Anxiety Inventory at Screen and/or Baseline Visits 11. Patients with history of suicide attempt within the last year or current suicidal ideation. Investigator must assess history of suicidality to determine if patient is at risk before entering the trial 12. Patients with history of other psychiatric disorders that could impact sexual function, risks patient safety, or may impact compliance. Axis I disorders (except anxiety symptoms and disorders) are excluded. Axis II disorders are allowed 13. Patients with significant cardiac, neurologic, hepatic, renal, hematologic, respiratory, gastrointestinal, immunological, endocrine disease 14. Patients with history of breast cancer or other cancer within the last 5 years, other than non-invasive, previously resected skin cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period. | 17 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12) | 12 weeks |
| The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12) | 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flibanserin 50 mg to 100 mg Qhs Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs | 45 |
| Flibanserin 100 mg Qhs Patient to receive 2 flibanserin tablets of 50 mg qhs | 28 |
| Placebo 2 Tablets Qhs Patient to receive 2 flibanserin placebo tablets of 50 mg qhs | 38 |
| Total | 111 |
Baseline characteristics
| Characteristic | Flibanserin 100 mg Qhs | Placebo 2 Tablets Qhs | Flibanserin 50 mg to 100 mg Qhs | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 38 Participants | 45 Participants | 111 Participants |
| Age, Continuous | 36.9 years STANDARD_DEVIATION 8 | 37.7 years STANDARD_DEVIATION 7.1 | 37.8 years STANDARD_DEVIATION 7.2 | 37.5 years STANDARD_DEVIATION 7.3 |
| Region of Enrollment United States | 28 participants | 38 participants | 45 participants | 111 participants |
| Sex: Female, Male Female | 28 Participants | 38 Participants | 45 Participants | 111 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 45 | 14 / 28 | 32 / 38 |
| serious Total, serious adverse events | 0 / 45 | 0 / 28 | 0 / 38 |
Outcome results
Primary
The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.
Time frame: 17 weeks
Population: The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flibanserin 50 mg to 100 mg Qhs | The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period. | 16 participants |
| Flibanserin 100 mg Qhs | The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period. | 14 participants |
| Placebo 2 Tablets Qhs | The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period. | 32 participants |
Secondary
The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)
Time frame: 12 weeks
Population: The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flibanserin 50 mg to 100 mg Qhs | The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12) | 8 participants |
| Flibanserin 100 mg Qhs | The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12) | 4 participants |
| Placebo 2 Tablets Qhs | The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12) | 1 participants |
Secondary
The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)
Time frame: 12 weeks
Population: The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flibanserin 50 mg to 100 mg Qhs | The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12) | 8 participants |
| Flibanserin 100 mg Qhs | The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12) | 6 participants |
| Placebo 2 Tablets Qhs | The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12) | 4 participants |