Sexual Dysfunctions, Psychological
Conditions
Brief summary
The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.
Interventions
DRUGflibanserin
patients will be randomized to flibanserin or placebo in a double-blind manner
DRUGplacebo
patients will be randomized to flibanserin or placebo in a double-blind manner
Sponsors
Sprout Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Naturally postmenopausal women of any age with at least one ovary * Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration * Stable, monogamous heterosexual relationship for at least one year * Willing to discuss sexual issues * Willing to engage in sexual activity at least once a month * Normal Pap smear * Normal mammogram * Normal uterine lining * Able to comply with daily use of handheld data entry device
Exclusion criteria
* Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition * Partner with inadequately treated organic or psychosexual dysfunction * Sexual function impaired by psychiatric disorder * Sexual function impaired by gynecological disorder * Major Depression * Suicidal behavior or ideation * Major life stress that could impair sexual function * Substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Number of Satisfying Sexual Events | baseline through 24 weeks | A small handheld electronic device (eDiary) was used by patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past. |
| Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain | baseline through 24 weeks | The FSFI© is a brief, self-administered questionnaire to assess key dimensions of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (with 1 being the lowest report of desire and 5 being the highest). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0 (the higher the score, the higher the reported level of desire). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) | change from baseline to 24 weeks | The FSDS© is a self-administered measure of female personal distress associated with sexual dysfunction. Question 13 inquires about distress specifically related to sexual desire. The range for each question, including Question 13, is 0 (Never) to 4 (Always). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flibanserin | 468 |
| Placebo | 481 |
| Total | 949 |
Baseline characteristics
| Characteristic | Flibanserin | Total | Placebo |
|---|---|---|---|
| Age, Customized 45-54 years | 192 participants | 405 participants | 213 participants |
| Age, Customized 55-64 | 248 participants | 485 participants | 237 participants |
| Age, Customized 65 years and older | 20 participants | 45 participants | 25 participants |
| Age, Customized less than 45 years | 8 participants | 14 participants | 6 participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 3 participants | 7 participants | 4 participants |
| Race/Ethnicity, Customized Asian | 4 participants | 8 participants | 4 participants |
| Race/Ethnicity, Customized Asian Hispanic | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black/African American | 35 participants | 62 participants | 27 participants |
| Race/Ethnicity, Customized Black/African American Hispanic | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Hawaiian/Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 398 participants | 820 participants | 422 participants |
| Race/Ethnicity, Customized White Hispanic | 28 participants | 51 participants | 23 participants |
| Sex: Female, Male Female | 468 Participants | 949 Participants | 481 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 150 / 468 | 62 / 481 |
| serious Total, serious adverse events | 8 / 468 | 4 / 481 |
Outcome results
Primary
Change From Baseline in the Number of Satisfying Sexual Events
A small handheld electronic device (eDiary) was used by patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.
Time frame: baseline through 24 weeks
Population: The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin 100mg | Change From Baseline in the Number of Satisfying Sexual Events | 1.0 sexual events | Standard Deviation 2.9 |
| Placebo | Change From Baseline in the Number of Satisfying Sexual Events | 0.6 sexual events | Standard Deviation 2.8 |
Primary
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
The FSFI© is a brief, self-administered questionnaire to assess key dimensions of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (with 1 being the lowest report of desire and 5 being the highest). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0 (the higher the score, the higher the reported level of desire).
Time frame: baseline through 24 weeks
Population: The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin 100mg | Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain | 0.7 units on a scale | Standard Deviation 0.1 |
| Placebo | Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain | 0.4 units on a scale | Standard Deviation 0.1 |
Secondary
Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R)
The FSDS© is a self-administered measure of female personal distress associated with sexual dysfunction. Question 13 inquires about distress specifically related to sexual desire. The range for each question, including Question 13, is 0 (Never) to 4 (Always).
Time frame: change from baseline to 24 weeks
Population: The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin 100mg | Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) | -0.8 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) | -0.6 units on a scale | Standard Error 0.1 |