Sexual Dysfunctions, Psychological
Conditions
Brief summary
Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens
Interventions
DRUGflibanserin flexible dose
Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.
Sponsors
Sprout Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with a primary diagnosis of HSDD who still needs to be treated according to the investigator's opinion and willing to continue in this study. This continuation requires adequate compliance, in the Investigators judgement, with trial medication and the trial visit required in the parent clinical trial (Visit 1 to visit 9). * Patients must have used a medically acceptable method of contraception \[i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive), intrauterine device, tubal sterilization, or partner's surgical sterilization\] for at least 3 months before the Screen Visit and continue to use that medically acceptable method of contraception during the trial.
Exclusion criteria
* 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, or patient with any non-zero statement in the first five items for the Beck Scale for Suicide Ideation. * Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Inclusion Visit. * Patients with findings at the Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy. * Patients experiencing major life stress (including parenting pressure, eldercare, loss of income, death of a family member, etc.) or relationship discord that could interfere with sexual activity, except distress about HSDD. * Clinically significant ECG abnormalities at the Screen Visit, according to the investigators opinion or the cardiologist who have performed the ECG. The following ECG values are considered to be exclusionary: QTc intervals \>480 milliseconds (ms), PR intervals \>240 ms, and QRS intervals \>110 ms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Adverse Events | 28 weeks |
Countries
Austria, Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flibanserin Flexible Dose Initial dosage:
Patients were to take one 50 mg flibanserin tablet in the evening.
Subsequent dosage titrations:
Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.
Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site.
flibanserin flexible dose: Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening.
Subsequent dosage titrations:
Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the pati | 480 |
| Total | 480 |
Baseline characteristics
| Characteristic | Flibanserin Flexible Dose |
|---|---|
| Age, Customized 18-29 years | 97 participants |
| Age, Customized 30-39 years | 211 participants |
| Age, Customized 40-49 years | 170 participants |
| Age, Customized 50 years and older | 2 participants |
| Race/Ethnicity, Customized Black | 4 participants |
| Race/Ethnicity, Customized Missing | 26 participants |
| Race/Ethnicity, Customized White | 442 participants |
| Race/Ethnicity, Customized White Hispanic | 8 participants |
| Sex: Female, Male Female | 480 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 | 275 / 480 |
| serious Total, serious adverse events | 9 / 480 |
Outcome results
Primary
Frequency of Adverse Events
Time frame: 28 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flibanserin Flexible Dose | Frequency of Adverse Events | patients with any adverse event | 331 participants with any adverse event |
| Flibanserin Flexible Dose | Frequency of Adverse Events | patients with drug-related adverse events | 206 participants with any adverse event |
| Flibanserin Flexible Dose | Frequency of Adverse Events | patients with adverse events leading to discontinu | 58 participants with any adverse event |
| Flibanserin Flexible Dose | Frequency of Adverse Events | patients with severe adverse events | 51 participants with any adverse event |
| Flibanserin Flexible Dose | Frequency of Adverse Events | patients with serious adverse events | 9 participants with any adverse event |