Trial Outcomes & Findings for 12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress (NCT NCT01040208)
NCT ID: NCT01040208
Last Updated: 2016-08-24
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
111 participants
Primary outcome timeframe
17 weeks
Results posted on
2016-08-24
Participant Flow
Participant milestones
| Measure |
Flibanserin 50 mg to 100 mg Qhs (Take Daily, at Bedtime)
Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
|
Flibanserin 100 mg Qhs
Patient to receive 2 flibanserin tablets of 50 mg qhs
|
Placebo 2 Tablets Qhs
Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
28
|
38
|
|
Overall Study
COMPLETED
|
39
|
15
|
35
|
|
Overall Study
NOT COMPLETED
|
6
|
13
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress
Baseline characteristics by cohort
| Measure |
Flibanserin 50 mg to 100 mg Qhs
n=45 Participants
Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
|
Flibanserin 100 mg Qhs
n=28 Participants
Patient to receive 2 flibanserin tablets of 50 mg qhs
|
Placebo 2 Tablets Qhs
n=38 Participants
Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
111 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
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
28 participants
n=7 Participants
|
38 participants
n=5 Participants
|
111 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 17 weeksPopulation: The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.
Outcome measures
| Measure |
Flibanserin 50 mg to 100 mg Qhs
n=45 Participants
Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
|
Flibanserin 100 mg Qhs
n=28 Participants
Patient to receive 2 flibanserin tablets of 50 mg qhs
|
Placebo 2 Tablets Qhs
n=38 Participants
Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
|
|---|---|---|---|
|
The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.
|
16 participants
|
14 participants
|
32 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.
Outcome measures
| Measure |
Flibanserin 50 mg to 100 mg Qhs
n=45 Participants
Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
|
Flibanserin 100 mg Qhs
n=28 Participants
Patient to receive 2 flibanserin tablets of 50 mg qhs
|
Placebo 2 Tablets Qhs
n=38 Participants
Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
|
|---|---|---|---|
|
The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)
|
8 participants
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.
Outcome measures
| Measure |
Flibanserin 50 mg to 100 mg Qhs
n=45 Participants
Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
|
Flibanserin 100 mg Qhs
n=28 Participants
Patient to receive 2 flibanserin tablets of 50 mg qhs
|
Placebo 2 Tablets Qhs
n=38 Participants
Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
|
|---|---|---|---|
|
The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)
|
8 participants
|
4 participants
|
1 participants
|
Adverse Events
Flibanserin 50 mg to 100 mg Qhs
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Flibanserin 100 mg Qhs
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo 2 Tablets Qhs
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flibanserin 50 mg to 100 mg Qhs
n=45 participants at risk
Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
|
Flibanserin 100 mg Qhs
n=28 participants at risk
Patient to receive 2 flibanserin tablets of 50 mg qhs
|
Placebo 2 Tablets Qhs
n=38 participants at risk
Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Increased appetite
|
2.2%
1/45 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
4.4%
2/45 • Number of events 2
|
7.1%
2/28 • Number of events 2
|
2.6%
1/38 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/45
|
7.1%
2/28 • Number of events 2
|
10.5%
4/38 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
0.00%
0/45
|
7.1%
2/28 • Number of events 2
|
5.3%
2/38 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/45 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
5.3%
2/38 • Number of events 3
|
|
Nervous system disorders
Headache
|
4.4%
2/45 • Number of events 2
|
7.1%
2/28 • Number of events 2
|
18.4%
7/38 • Number of events 7
|
|
Nervous system disorders
Sedation
|
4.4%
2/45 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
0.00%
0/45
|
3.6%
1/28 • Number of events 1
|
7.9%
3/38 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
2/45 • Number of events 2
|
0.00%
0/28
|
5.3%
2/38 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
3/45 • Number of events 3
|
3.6%
1/28 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/45
|
0.00%
0/28
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Fatigue
|
4.4%
2/45 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
Investigations
Weight increased
|
2.2%
1/45 • Number of events 1
|
0.00%
0/28
|
5.3%
2/38 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place