Trial Outcomes & Findings for Flibanserin Versus Placebo in Premenopausal Women With HSDD (NCT NCT00491829)
NCT ID: NCT00491829
Last Updated: 2014-06-02
Results Overview
To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered "yes" to the eDiary question: "Was the event satisfying for you?"
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
945 participants
Primary outcome timeframe
baseline to 24 weeks
Results posted on
2014-06-02
Participant Flow
Participant milestones
| Measure |
Flibanserin 50mg
50 mg qhs
BIMT 17 BS 50 mg: flibanserin 50 mg
|
Flibanserin 100mg
100 mg qhs
BIMT 17 BS 100 mg: flibanserin 100mg
|
Placebo
placebo qhs
placebo: placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
311
|
316
|
318
|
|
Overall Study
COMPLETED
|
216
|
202
|
243
|
|
Overall Study
NOT COMPLETED
|
95
|
114
|
75
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Flibanserin Versus Placebo in Premenopausal Women With HSDD
Baseline characteristics by cohort
| Measure |
Flibanserin 50mg
n=311 Participants
50 mg qhs
BIMT 17 BS 50 mg: flibanserin 50 mg
|
Flibanserin 100mg
n=316 Participants
100 mg qhs
BIMT 17 BS 100 mg: flibanserin 100mg
|
Placebo
n=318 Participants
placebo qhs
placebo: placebo
|
Total
n=945 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-34 years
|
145 participants
n=99 Participants
|
128 participants
n=107 Participants
|
148 participants
n=206 Participants
|
421 participants
n=7 Participants
|
|
Age, Customized
35-44 years
|
133 participants
n=99 Participants
|
157 participants
n=107 Participants
|
147 participants
n=206 Participants
|
437 participants
n=7 Participants
|
|
Age, Customized
45 years and older
|
33 participants
n=99 Participants
|
31 participants
n=107 Participants
|
23 participants
n=206 Participants
|
87 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
311 Participants
n=99 Participants
|
316 Participants
n=107 Participants
|
318 Participants
n=206 Participants
|
945 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
276 participants
n=99 Participants
|
281 participants
n=107 Participants
|
286 participants
n=206 Participants
|
843 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
6 participants
n=99 Participants
|
9 participants
n=107 Participants
|
3 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black Hispanic
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian Hispanic
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Missing
|
26 participants
n=99 Participants
|
22 participants
n=107 Participants
|
26 participants
n=206 Participants
|
74 participants
n=7 Participants
|
|
Region of Enrollment
Finland
|
18 participants
n=99 Participants
|
17 participants
n=107 Participants
|
18 participants
n=206 Participants
|
53 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
2 participants
n=206 Participants
|
15 participants
n=7 Participants
|
|
Region of Enrollment
Austria
|
16 participants
n=99 Participants
|
20 participants
n=107 Participants
|
19 participants
n=206 Participants
|
55 participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
10 participants
n=206 Participants
|
29 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
31 participants
n=99 Participants
|
34 participants
n=107 Participants
|
35 participants
n=206 Participants
|
100 participants
n=7 Participants
|
|
Region of Enrollment
France
|
27 participants
n=99 Participants
|
27 participants
n=107 Participants
|
28 participants
n=206 Participants
|
82 participants
n=7 Participants
|
|
Region of Enrollment
Hungary
|
19 participants
n=99 Participants
|
18 participants
n=107 Participants
|
18 participants
n=206 Participants
|
55 participants
n=7 Participants
|
|
Region of Enrollment
Czech Republic
|
22 participants
n=99 Participants
|
20 participants
n=107 Participants
|
21 participants
n=206 Participants
|
63 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
27 participants
n=99 Participants
|
27 participants
n=107 Participants
|
28 participants
n=206 Participants
|
82 participants
n=7 Participants
|
|
Region of Enrollment
Netherlands
|
30 participants
n=99 Participants
|
32 participants
n=107 Participants
|
34 participants
n=206 Participants
|
96 participants
n=7 Participants
|
|
Region of Enrollment
Norway
|
11 participants
n=99 Participants
|
13 participants
n=107 Participants
|
10 participants
n=206 Participants
|
34 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
56 participants
n=99 Participants
|
54 participants
n=107 Participants
|
55 participants
n=206 Participants
|
165 participants
n=7 Participants
|
|
Region of Enrollment
Sweden
|
39 participants
n=99 Participants
|
37 participants
n=107 Participants
|
40 participants
n=206 Participants
|
116 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline to 24 weeksPopulation: Patients who had at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). The FAS was used for primary analyses.
To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered "yes" to the eDiary question: "Was the event satisfying for you?"
Outcome measures
| Measure |
Flibanserin 50mg
n=297 Participants
50 mg qhs
BIMT 17 BS 50 mg: flibanserin 50 mg
|
Flibanserin 100mg
n=299 Participants
100 mg qhs
BIMT 17 BS 100 mg: flibanserin 100mg
|
Placebo
n=307 Participants
placebo qhs
placebo: placebo
|
|---|---|---|---|
|
Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
|
1.2 events per month
Standard Deviation 3.7
|
1.5 events per month
Standard Deviation 4.0
|
0.9 events per month
Standard Deviation 3.2
|
Adverse Events
Flibanserin 50mg
Serious events: 25 serious events
Other events: 174 other events
Deaths: 0 deaths
Flibanserin 100mg
Serious events: 19 serious events
Other events: 238 other events
Deaths: 0 deaths
Placebo
Serious events: 16 serious events
Other events: 143 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flibanserin 50mg
n=311 participants at risk
50 mg qhs
BIMT 17 BS 50 mg: flibanserin 50 mg
|
Flibanserin 100mg
n=316 participants at risk
100 mg qhs
BIMT 17 BS 100 mg: flibanserin 100mg
|
Placebo
n=318 participants at risk
placebo qhs
placebo: placebo
|
|---|---|---|---|
|
Renal and urinary disorders
haematuria
|
0.00%
0/311
|
0.00%
0/316
|
0.31%
1/318 • Number of events 1
|
|
Hepatobiliary disorders
cholelithiasis
|
0.00%
0/311
|
0.00%
0/316
|
0.31%
1/318 • Number of events 1
|
|
Reproductive system and breast disorders
ovarian cyst ruptured
|
0.00%
0/311
|
0.00%
0/316
|
0.31%
1/318 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc protrusion
|
0.64%
2/311 • Number of events 3
|
0.00%
0/316
|
0.00%
0/318
|
|
Gastrointestinal disorders
abdominal pain
|
2.9%
9/311 • Number of events 12
|
1.9%
6/316 • Number of events 6
|
1.9%
6/318 • Number of events 6
|
|
Nervous system disorders
gliosis
|
0.32%
1/311 • Number of events 1
|
0.00%
0/316
|
0.00%
0/318
|
|
Injury, poisoning and procedural complications
thoracic vertebral fracture
|
0.32%
1/311 • Number of events 1
|
0.00%
0/316
|
0.00%
0/318
|
|
Reproductive system and breast disorders
metrorrhagia
|
3.9%
12/311 • Number of events 14
|
2.8%
9/316 • Number of events 13
|
1.9%
6/318 • Number of events 9
|
|
Psychiatric disorders
suicide attempt
|
0.00%
0/311
|
0.32%
1/316 • Number of events 1
|
0.00%
0/318
|
|
Gastrointestinal disorders
subileus
|
0.00%
0/311
|
0.32%
1/316 • Number of events 1
|
0.00%
0/318
|
|
Vascular disorders
circulatory collapse
|
0.00%
0/311
|
0.32%
1/316 • Number of events 1
|
0.31%
1/318 • Number of events 1
|
|
Injury, poisoning and procedural complications
concussion
|
0.32%
1/311 • Number of events 1
|
0.32%
1/316 • Number of events 1
|
0.00%
0/318
|
Other adverse events
| Measure |
Flibanserin 50mg
n=311 participants at risk
50 mg qhs
BIMT 17 BS 50 mg: flibanserin 50 mg
|
Flibanserin 100mg
n=316 participants at risk
100 mg qhs
BIMT 17 BS 100 mg: flibanserin 100mg
|
Placebo
n=318 participants at risk
placebo qhs
placebo: placebo
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
15.8%
49/311 • Number of events 91
|
16.8%
53/316 • Number of events 66
|
13.2%
42/318 • Number of events 67
|
|
Nervous system disorders
Dizziness
|
7.4%
23/311 • Number of events 25
|
14.6%
46/316 • Number of events 55
|
4.4%
14/318 • Number of events 16
|
|
Nervous system disorders
Somnolence
|
3.9%
12/311 • Number of events 12
|
5.1%
16/316 • Number of events 17
|
0.94%
3/318 • Number of events 3
|
|
Infections and infestations
nasopharyngitis
|
11.6%
36/311 • Number of events 45
|
9.5%
30/316 • Number of events 35
|
10.1%
32/318 • Number of events 37
|
|
Gastrointestinal disorders
nausea
|
6.1%
19/311 • Number of events 20
|
12.3%
39/316 • Number of events 49
|
6.0%
19/318 • Number of events 20
|
|
General disorders
Fatigue
|
11.3%
35/311 • Number of events 41
|
17.1%
54/316 • Number of events 67
|
10.4%
33/318 • Number of events 36
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place