Sexual Dysfunctions, Psychological
Conditions
Brief summary
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women. To evaluate safety and tolerability of flibanserin in such patients.
Interventions
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Women who are 18 years of age and older at the Screen Visit. 2. Premenopausal women per the Stages of Reproductive Aging Workshop (STRAW) criteria with the primary diagnosis of HSDD, generalized acquired type, according to DSM IV-TR criteria. The current episode must be at least 24 weeks in duration by the Baseline Visit. Secondary Female Sexual Arousal Disorder and/or Female Orgasmic Disorder are allowed. This inclusion criterion is met only if the HSDD commenced prior to Female Sexual Arousal Disorder and/or Female Orgasmic Disorder and the HSDD is of more importance to the patient, in the investigator judgement 3. A score of 15 or higher on the Female Sexual Distress Scale-Revised (FSDS-R)© (R04-1068) at the Screen Visit. 4. Item Number Two of the Sexual Interest and Desire Inventory - Female© (SIDI-F©) must be rated as 0 or 1 at the Screen Visit 5. Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly. 6. Patients must be willing and able to use an eDiary on a daily basis (e.g., have access to a working land line or wireless telephone for daily data transmissions). 7. At the Baseline Visit, patients must have complied with eDiary use adequately, having missing entries for five or less days during the 28-day Screen period. 8. Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The relationship is to be with the same partner who is sexually functional, both psychologically and physically, and the partner is expected to be physically present (i.e., available for sexual activity at some time during a 24 hour day) at least 50% of each month during the 4-week Screen period and 24-week efficacy period of the trial.
Exclusion criteria
1. Patients who have taken any medication noted in Appendix 10.6.1, Part I - List of prohibited medications, within 30 days before the Screen Visit; the same medications are prohibited throughout participation in the study. 2. Patients whose sexual function was affected (enhanced or worsened) in the investigator opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit. This must be determined by the investigator judgement after performing a detailed review of the patient sexual history and concomitant therapy. 3. Patients with a history of drug dependence or abuse (including alcohol, as defined in DSM IV-TR or in the opinion of the investigator) within the past 1 year 4. Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia (not caused by inadequate foreplay stimulation or alleviated by lubricants), Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction Due to a General Medical Condition. 5. Patients who indicate that their sexual partner has organic or psychosexual dysfunction that could interfere with a patient response to treatment. 6. Patients who have entered the peri-menopause stage (menopausal transition) or the post menopause stage \[i.e., have had hysterectomy (without bilateral oophorectomy), bilateral oophorectomy, endometrial ablation (any type), and chemical induced (e.g., chemotherapy)\] according to the STRAW criteria. 7. Patients with a history of MDD within 6 months prior the Screen Visit or a score of 14 on the Beck Depression Inventory© II, or a history of suicide attempt according to the Beck Scale for Suicide Ideation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary. | baseline to 24 weeks | To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered yes to the eDiary question: Was the event satisfying for you? |
Countries
Austria, Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flibanserin 50mg 50 mg qhs
BIMT 17 BS 50 mg: flibanserin 50 mg | 311 |
| Flibanserin 100mg 100 mg qhs
BIMT 17 BS 100 mg: flibanserin 100mg | 316 |
| Placebo placebo qhs
placebo: placebo | 318 |
| Total | 945 |
Baseline characteristics
| Characteristic | Placebo | Flibanserin 100mg | Total | Flibanserin 50mg |
|---|---|---|---|---|
| Age, Customized 18-34 years | 148 participants | 128 participants | 421 participants | 145 participants |
| Age, Customized 35-44 years | 147 participants | 157 participants | 437 participants | 133 participants |
| Age, Customized 45 years and older | 23 participants | 31 participants | 87 participants | 33 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized Asian Hispanic | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black | 3 participants | 3 participants | 8 participants | 2 participants |
| Race/Ethnicity, Customized Black Hispanic | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Missing | 26 participants | 22 participants | 74 participants | 26 participants |
| Race/Ethnicity, Customized White | 286 participants | 281 participants | 843 participants | 276 participants |
| Race/Ethnicity, Customized White Hispanic | 3 participants | 9 participants | 18 participants | 6 participants |
| Region of Enrollment Austria | 19 participants | 20 participants | 55 participants | 16 participants |
| Region of Enrollment Belgium | 28 participants | 27 participants | 82 participants | 27 participants |
| Region of Enrollment Czech Republic | 21 participants | 20 participants | 63 participants | 22 participants |
| Region of Enrollment Finland | 18 participants | 17 participants | 53 participants | 18 participants |
| Region of Enrollment France | 28 participants | 27 participants | 82 participants | 27 participants |
| Region of Enrollment Germany | 55 participants | 54 participants | 165 participants | 56 participants |
| Region of Enrollment Hungary | 18 participants | 18 participants | 55 participants | 19 participants |
| Region of Enrollment Italy | 10 participants | 9 participants | 29 participants | 10 participants |
| Region of Enrollment Netherlands | 34 participants | 32 participants | 96 participants | 30 participants |
| Region of Enrollment Norway | 10 participants | 13 participants | 34 participants | 11 participants |
| Region of Enrollment Spain | 2 participants | 8 participants | 15 participants | 5 participants |
| Region of Enrollment Sweden | 40 participants | 37 participants | 116 participants | 39 participants |
| Region of Enrollment United Kingdom | 35 participants | 34 participants | 100 participants | 31 participants |
| Sex: Female, Male Female | 318 Participants | 316 Participants | 945 Participants | 311 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 | 174 / 311 | 238 / 316 | 143 / 318 |
| serious Total, serious adverse events | 25 / 311 | 19 / 316 | 16 / 318 |
Outcome results
Primary
Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered yes to the eDiary question: Was the event satisfying for you?
Time frame: baseline to 24 weeks
Population: Patients who had at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). The FAS was used for primary analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin 50mg | Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary. | 1.2 events per month | Standard Deviation 3.7 |
| Flibanserin 100mg | Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary. | 1.5 events per month | Standard Deviation 4 |
| Placebo | Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary. | 0.9 events per month | Standard Deviation 3.2 |