Trial Outcomes & Findings for 24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder (NCT NCT00360529)
NCT ID: NCT00360529
Last Updated: 2016-06-27
Results Overview
Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.
COMPLETED
PHASE3
880 participants
Baseline, Week 24
2016-06-27
Participant Flow
Participant milestones
| Measure |
Placebo
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Overall Study
STARTED
|
295
|
295
|
290
|
|
Overall Study
COMPLETED
|
234
|
230
|
199
|
|
Overall Study
NOT COMPLETED
|
61
|
65
|
91
|
Reasons for withdrawal
| Measure |
Placebo
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
23
|
33
|
|
Overall Study
Protocol Violation
|
3
|
3
|
11
|
|
Overall Study
Lost to Follow-up
|
14
|
10
|
13
|
|
Overall Study
Withdrawal by Subject
|
22
|
14
|
18
|
|
Overall Study
Lack of Efficacy
|
8
|
6
|
5
|
|
Overall Study
Reason discontinued not explained above
|
4
|
9
|
11
|
Baseline Characteristics
24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=295 Participants
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
n=295 Participants
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
n=290 Participants
Flibanserin 100 mg at bedtime
|
Total
n=880 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
35.6 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
|
Age, Customized
18 - 34 years
|
126 participants
n=5 Participants
|
127 participants
n=7 Participants
|
134 participants
n=5 Participants
|
387 participants
n=4 Participants
|
|
Age, Customized
35 - 44 years
|
136 participants
n=5 Participants
|
125 participants
n=7 Participants
|
118 participants
n=5 Participants
|
379 participants
n=4 Participants
|
|
Age, Customized
>= 45 years
|
33 participants
n=5 Participants
|
43 participants
n=7 Participants
|
38 participants
n=5 Participants
|
114 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
295 Participants
n=5 Participants
|
295 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
880 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
235 participants
n=5 Participants
|
237 participants
n=7 Participants
|
229 participants
n=5 Participants
|
701 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
21 participants
n=5 Participants
|
26 participants
n=7 Participants
|
19 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black Hispanic
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
35 participants
n=5 Participants
|
95 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
66 participants
n=5 Participants
|
69 participants
n=7 Participants
|
66 participants
n=5 Participants
|
201 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
229 participants
n=5 Participants
|
226 participants
n=7 Participants
|
224 participants
n=5 Participants
|
679 participants
n=4 Participants
|
|
Marital Status
Unmarried
|
58 participants
n=5 Participants
|
81 participants
n=7 Participants
|
61 participants
n=5 Participants
|
200 participants
n=4 Participants
|
|
Marital Status
Married
|
237 participants
n=5 Participants
|
214 participants
n=7 Participants
|
229 participants
n=5 Participants
|
680 participants
n=4 Participants
|
|
Education level
Partial high school
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Education level
High school graduate or equivalent
|
35 participants
n=5 Participants
|
33 participants
n=7 Participants
|
26 participants
n=5 Participants
|
94 participants
n=4 Participants
|
|
Education level
Partial college/university
|
78 participants
n=5 Participants
|
80 participants
n=7 Participants
|
85 participants
n=5 Participants
|
243 participants
n=4 Participants
|
|
Education level
College/university graduate
|
139 participants
n=5 Participants
|
131 participants
n=7 Participants
|
130 participants
n=5 Participants
|
400 participants
n=4 Participants
|
|
Education level
Post-graduate/professional degree
|
42 participants
n=5 Participants
|
45 participants
n=7 Participants
|
46 participants
n=5 Participants
|
133 participants
n=4 Participants
|
|
Education level
Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Employment status
Full time (>= 40 hours/week)
|
195 participants
n=5 Participants
|
194 participants
n=7 Participants
|
180 participants
n=5 Participants
|
569 participants
n=4 Participants
|
|
Employment status
Part time (17-39 hours/week)
|
54 participants
n=5 Participants
|
58 participants
n=7 Participants
|
48 participants
n=5 Participants
|
160 participants
n=4 Participants
|
|
Employment status
Occassional (1-16 hours/week)
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Employment status
Full time homemaker
|
33 participants
n=5 Participants
|
28 participants
n=7 Participants
|
31 participants
n=5 Participants
|
92 participants
n=4 Participants
|
|
Employment status
Unemployed
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Employment status
Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
How long in present relationship
|
10.39 years
STANDARD_DEVIATION 6.50 • n=5 Participants
|
11.05 years
STANDARD_DEVIATION 6.94 • n=7 Participants
|
10.48 years
STANDARD_DEVIATION 6.38 • n=5 Participants
|
10.64 years
STANDARD_DEVIATION 6.61 • n=4 Participants
|
|
Alcohol status
Non drinker
|
68 participants
n=5 Participants
|
83 participants
n=7 Participants
|
78 participants
n=5 Participants
|
229 participants
n=4 Participants
|
|
Alcohol status
Drinks - no interference
|
227 participants
n=5 Participants
|
212 participants
n=7 Participants
|
212 participants
n=5 Participants
|
651 participants
n=4 Participants
|
|
Alcohol status
Drinks - possible interference
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Smoking history
Never smoked
|
200 participants
n=5 Participants
|
202 participants
n=7 Participants
|
206 participants
n=5 Participants
|
608 participants
n=4 Participants
|
|
Smoking history
Ex-smoker
|
60 participants
n=5 Participants
|
56 participants
n=7 Participants
|
55 participants
n=5 Participants
|
171 participants
n=4 Participants
|
|
Smoking history
Currently smokes
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
29 participants
n=5 Participants
|
101 participants
n=4 Participants
|
|
Smoking history - pack years
|
6.72 pack years
STANDARD_DEVIATION 7.27 • n=5 Participants
|
6.46 pack years
STANDARD_DEVIATION 6.09 • n=7 Participants
|
6.07 pack years
STANDARD_DEVIATION 8.26 • n=5 Participants
|
6.43 pack years
STANDARD_DEVIATION 7.20 • n=4 Participants
|
|
Weight
|
71.09 kilograms
STANDARD_DEVIATION 15.31 • n=5 Participants
|
72.78 kilograms
STANDARD_DEVIATION 17.05 • n=7 Participants
|
74.19 kilograms
STANDARD_DEVIATION 17.53 • n=5 Participants
|
72.68 kilograms
STANDARD_DEVIATION 16.68 • n=4 Participants
|
|
Body mass index
|
26.35 kilogram/square meter
STANDARD_DEVIATION 6.07 • n=5 Participants
|
26.90 kilogram/square meter
STANDARD_DEVIATION 6.13 • n=7 Participants
|
27.04 kilogram/square meter
STANDARD_DEVIATION 5.85 • n=5 Participants
|
26.76 kilogram/square meter
STANDARD_DEVIATION 6.02 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: 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 FAS was analyzed for efficacy.
Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.
Outcome measures
| Measure |
Placebo
n=285 Participants
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
n=291 Participants
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
n=275 Participants
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Satisfying Sexual Event Monthly Change From Baseline at Final Visit
|
0.8 number of events
Standard Deviation 3.4
|
1.4 number of events
Standard Deviation 3.6
|
1.6 number of events
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: 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 FAS was analyzed for efficacy.
Change from baseline in eDiary Sexual Desire Monthly Total Score standardized to a 28-day period. Change from baseline calculated as the difference between the 4 week baseline period and Week 21 to Week 24. Patients recorded information daily throughout trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read "Indicate your most intense level of sexual desire in the last 24 hours/since your last visit." Potential responses included "no," "low," "moderate," or "strong", scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire): 0 = No desire 1. = Low desire 2. = Moderate desire 3. = Strong desire Total score ranged from 0-84, with higher scores reflecting stronger desire). Monthly desire score was calculated as 28 x (sum of daily desire scores/number of responses).
Outcome measures
| Measure |
Placebo
n=285 Participants
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
n=291 Participants
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
n=275 Participants
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit
|
6.9 units on a scale
Standard Error 0.9
|
8.2 units on a scale
Standard Error 0.9
|
9.1 units on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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 FAS was analyzed for efficacy.
Change from baseline in the Female Sexual Distress Scale - revised (FSDS-R) Total Score with a seven day recall period. The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The maximum total score of the FSDS-R is '52' (score of minimum of 0 and maximum of 4 for each item) and indicates the maximum level of sexual distress (the higher the score, the higher the level of reported sexual desire).
Outcome measures
| Measure |
Placebo
n=289 Participants
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
n=293 Participants
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
n=280 Participants
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit
|
-4.9 score on a scale
Standard Error 0.7
|
-6.1 score on a scale
Standard Error 0.7
|
-8.9 score on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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 FAS was analyzed for efficacy.
Change from baseline in the FSDS-R Question 13 (Bothered by low sexual desire). The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The scoring for item 13 is from 0-4, with 4 indicating the highest level of sexual distress.
Outcome measures
| Measure |
Placebo
n=289 Participants
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
n=293 Participants
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
n=280 Participants
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit
|
-0.5 score on a scale
Standard Error 0.1
|
-0.6 score on a scale
Standard Error 0.1
|
-0.8 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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 FAS was analyzed for efficacy.
Female Sexual Function Inventory (FSFI) Desire Domain assesses sexual desire or interest with 2 questions ranging from 1 (very low) to 5 (very high). The domain total score is multiplied by 0.6 yielding scores ranging from 1.2 to 6 (higher scores = higher level of desire or interest).
Outcome measures
| Measure |
Placebo
n=290 Participants
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
n=293 Participants
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
n=280 Participants
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit
|
0.5 score on a scale
Standard Error 0.1
|
0.8 score on a scale
Standard Error 0.1
|
0.9 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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 FAS was analyzed for efficacy.
The FSFI© is a self-administered questionnaire to assess FSD, which consists of 19 questions that are scored from '0' to '5.' The scale contains six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate higher levels of the domain assessed. The total score is a weighted average of the six domains, each contributing a maximum of 6 points to the total, so the minimum score is 2, while the maximum score of FSFI© is 36.
Outcome measures
| Measure |
Placebo
n=289 Participants
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
n=292 Participants
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
n=280 Participants
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit
|
2.4 score on a scale
Standard Error 0.4
|
3.9 score on a scale
Standard Error 0.4
|
5.0 score on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Week 24Population: This question was asked at Week 24 only, so did not include participants who had discontinued the trial prior to that time (e.g., analysis population includes treatment completers only).
The Patient Benefit Evaluation is a single question asking the patient whether or not she experienced a meaningful benefit from the study medication during the trial. This question ("Overall, do you believe that you have experienced a meaningful benefit from the study medication?") was asked upon treatment discontinuation.
Outcome measures
| Measure |
Placebo
n=266 Participants
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
n=271 Participants
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
n=254 Participants
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Patient Benefit Evaluation
Meaningful benefit from medication
|
71 participants
|
94 participants
|
98 participants
|
|
Patient Benefit Evaluation
No meaningful benefit from medication
|
195 participants
|
177 participants
|
156 participants
|
Adverse Events
Placebo
Flibanserin 50 mg q.h.s.
Flibanserin 100 mg q.h.s
Serious adverse events
| Measure |
Placebo
n=295 participants at risk
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
n=295 participants at risk
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
n=290 participants at risk
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/295
|
0.00%
0/295
|
0.34%
1/290 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/295
|
0.00%
0/295
|
0.34%
1/290 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/295
|
0.34%
1/295 • Number of events 1
|
0.00%
0/290
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/295
|
0.34%
1/295 • Number of events 1
|
0.00%
0/290
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/295
|
0.34%
1/295 • Number of events 1
|
0.00%
0/290
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/295
|
0.00%
0/295
|
0.34%
1/290 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/295
|
0.00%
0/295
|
0.34%
1/290 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/295
|
0.00%
0/295
|
0.34%
1/290 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=295 participants at risk
placebo at bedtime
|
Flibanserin 50 mg q.h.s.
n=295 participants at risk
Flibanserin 50 mg at bedtime
|
Flibanserin 100 mg q.h.s
n=290 participants at risk
Flibanserin 100 mg at bedtime
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.1%
12/295 • Number of events 12
|
7.8%
23/295 • Number of events 23
|
11.4%
33/290 • Number of events 33
|
|
General disorders
Fatigue
|
2.7%
8/295 • Number of events 8
|
3.4%
10/295 • Number of events 10
|
6.2%
18/290 • Number of events 18
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
24/295 • Number of events 24
|
8.8%
26/295 • Number of events 26
|
6.2%
18/290 • Number of events 18
|
|
Infections and infestations
Sinusitis
|
3.1%
9/295 • Number of events 9
|
2.4%
7/295 • Number of events 7
|
6.2%
18/290 • Number of events 18
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
15/295 • Number of events 15
|
7.5%
22/295 • Number of events 22
|
4.5%
13/290 • Number of events 13
|
|
Nervous system disorders
Dizziness
|
1.7%
5/295 • Number of events 5
|
5.1%
15/295 • Number of events 15
|
9.0%
26/290 • Number of events 26
|
|
Nervous system disorders
Headache
|
9.2%
27/295 • Number of events 27
|
7.5%
22/295 • Number of events 27
|
7.6%
22/290 • Number of events 22
|
|
Nervous system disorders
Somnolence
|
3.1%
9/295 • Number of events 9
|
8.8%
26/295 • Number of events 26
|
11.0%
32/290 • Number of events 32
|
|
Psychiatric disorders
Insomnia
|
5.4%
16/295 • Number of events 16
|
1.7%
5/295 • Number of events 5
|
7.2%
21/290 • Number of events 21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Sprout Pharmaceuticals publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
- Publication restrictions are in place
Restriction type: OTHER