Sexual Dysfunctions, Psychological
Conditions
Brief summary
The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal 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
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Premenopausal women who are 18 years old and older 2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration. 3. Stable, monogamous heterosexual relationship for at least one year. 4. Willing to discuss sexual issues. 5. Willing to engage in sexual activity at least once a month 6. Normal pap smear 7. Must use medically acceptable method of contraception 8. Able to comply with daily use of a handheld entry device
Exclusion criteria
1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit. 2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition. 3. Partner with inadequately treated organic or psychosexual dysfunction 4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior. 5. Sexual function impaired by psychiatric disorder 6. Sexual function impaired by gynecological disorder 7. Major life stress that could impair sexual function 8. Substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. | 24 weeks | The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 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 on the desire domain, the higher the level of reported sexual desire. |
| Change From Baseline in the SSE Count From Baseline to 24 Weeks | 24 weeks | The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The 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. An eDiary was used by the 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 entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flibanserin 100 mg flibanserin 100mg po qd | 543 |
| Placebo placebo 1 tab po qd | 547 |
| Total | 1,090 |
Baseline characteristics
| Characteristic | Total | Flibanserin 100 mg | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1090 Participants | 543 Participants | 547 Participants |
| Age, Continuous | 36.5 years STANDARD_DEVIATION 7.3 | 36.5 years STANDARD_DEVIATION 7.8 | 36.6 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 1090 participants | 543 participants | 547 participants |
| Sex: Female, Male Female | 1090 Participants | 543 Participants | 547 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 | 237 / 543 | 68 / 547 |
| serious Total, serious adverse events | 4 / 543 | 2 / 547 |
Outcome results
Primary
Change From Baseline in the SSE Count From Baseline to 24 Weeks
The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The 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. An eDiary was used by the 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 entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.
Time frame: 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, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin 100 mg | Change From Baseline in the SSE Count From Baseline to 24 Weeks | 2.5 SSEs | Standard Deviation 4.6 |
| Placebo | Change From Baseline in the SSE Count From Baseline to 24 Weeks | 1.5 SSEs | Standard Deviation 4.5 |
Primary
The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.
The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 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 on the desire domain, the higher the level of reported sexual desire.
Time frame: 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, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flibanserin 100 mg | The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. | 1.0 units on a scale | Standard Error 0.1 |
| Placebo | The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. | 0.7 units on a scale | Standard Error 0.1 |