Sexual Dysfunctions, Psychological
Conditions
Brief summary
To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.
Interventions
DRUGFlibanserin
flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
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 55 Years
Healthy volunteers
No
Inclusion criteria
1. Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin. 2. Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study. 3. Patients must be reliable, compliant, and agree to cooperate with all study evaluations. 4. Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff.
Exclusion criteria
1. A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt. 2. Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin. 3. Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy. 4. Patients who are pregnant or have been pregnant within 1 month prior to study start. 5. Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD. 6. Clinically significant ECG or lab abnormalities at study start. 7. Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Frequency of Adverse Events (Side Effects). | 52 weeks | This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flibanserin Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily. | 1,723 |
| Total | 1,723 |
Baseline characteristics
| Characteristic | Flibanserin |
|---|---|
| Age, Customized 18-29 years | 266 participants |
| Age, Customized 30-39 years | 749 participants |
| Age, Customized 40-49 years | 672 participants |
| Age, Customized 50 years and older | 36 participants |
| Race/Ethnicity, Customized Asian | 21 participants |
| Race/Ethnicity, Customized Black | 119 participants |
| Race/Ethnicity, Customized Black Hispanic | 6 participants |
| Race/Ethnicity, Customized White | 1492 participants |
| Race/Ethnicity, Customized White Hispanic | 85 participants |
| Sex: Female, Male Female | 1723 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 | 995 / 1,723 |
| serious Total, serious adverse events | 15 / 1,723 |
Outcome results
Primary
The Frequency of Adverse Events (Side Effects).
This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flibanserin | The Frequency of Adverse Events (Side Effects). | 1272 participants with any adverse event |