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
Flibanserin 100mg administered at bedtime for 24 weeks
DRUGPlacebo
This is the matched placebo which will be administered two tablets daily at bedtime.
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 to 24 weeks | The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question. |
| Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain | baseline to 24 weeks | The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains 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 (1 is lowest level of desire and 5 is the highest level of desire). 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 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flibanserin 100 mg Flibanserin 100 mg administered at bedtime
Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks | 376 |
| Placebo This is the matched placebo which will be administered two tablets daily at bedtime.
Placebo: This is the matched placebo which will be administered two tablets daily at bedtime. | 372 |
| Total | 748 |
Baseline characteristics
| Characteristic | Flibanserin 100 mg | Total | Placebo |
|---|---|---|---|
| Age, Customized 45-54 years | 154 participants | 282 participants | 128 participants |
| Age, Customized 55-64 | 196 participants | 408 participants | 212 participants |
| Age, Customized 65 years and older | 22 participants | 49 participants | 27 participants |
| Age, Customized less than 45 years | 4 participants | 9 participants | 5 participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 8 participants | 12 participants | 4 participants |
| Race/Ethnicity, Customized Asian Hispanic | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black/African American | 25 participants | 51 participants | 26 participants |
| Race/Ethnicity, Customized Black/African American Hispanic | 1 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized Hawaiian/Pacific Islander | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized White | 324 participants | 634 participants | 310 participants |
| Race/Ethnicity, Customized White Hispanic | 18 participants | 45 participants | 27 participants |
| Sex: Female, Male Female | 376 Participants | 748 Participants | 372 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 | 118 / 376 | 74 / 369 |
| serious Total, serious adverse events | 6 / 376 | 4 / 369 |
Outcome results
Primary
Change From Baseline in the Number of Satisfying Sexual Events
The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
Time frame: 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 usable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin 100 mg | Change From Baseline in the Number of Satisfying Sexual Events | 1.0 SSEs/month | Standard Deviation 3.3 |
| Placebo | Change From Baseline in the Number of Satisfying Sexual Events | 0.7 SSEs/month | Standard Deviation 2.9 |
Primary
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains 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 (1 is lowest level of desire and 5 is the highest level of desire). 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 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.
Time frame: 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 usable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin 100 mg | Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain | 0.6 units on a scale | Standard Error 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 Error 0.1 |