Trial Outcomes & Findings for Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder (NCT NCT00360555)
NCT ID: NCT00360555
Last Updated: 2016-06-27
Results Overview
For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms. For satisfying sexual events: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1584 participants
Primary outcome timeframe
baseline to 28 weeks
Results posted on
2016-06-27
Participant Flow
Participant milestones
| Measure |
Flibanserin 25 mg b.i.d
flibanserin: 25 mg twice daily
|
Flibanserin 50mg Qhs/b.i.d
flibanserin: 50 mg once at bedtime/twice daily
|
Flibanserin 50mg b.i.d./100mg Qhs
flibanserin: 50 mg twice daily/100 once at bedtime
|
Placebo
flibanserin: placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
396
|
393
|
396
|
399
|
|
Overall Study
COMPLETED
|
274
|
259
|
251
|
287
|
|
Overall Study
NOT COMPLETED
|
122
|
134
|
145
|
112
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
Baseline characteristics by cohort
| Measure |
Flibanserin 25 mg b.i.d
n=396 Participants
flibanserin: 25 mg twice daily
|
Flibanserin 50mg Qhs/b.i.d
n=392 Participants
flibanserin: 50 mg once at bedtime/twice daily
|
Flibanserin 50mg b.i.d./100mg Qhs
n=395 Participants
flibanserin: 50 mg twice daily/100 once at bedtime
|
Placebo
n=398 Participants
flibanserin: placebo
|
Total
n=1581 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
396 Participants
n=5 Participants
|
392 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
398 Participants
n=4 Participants
|
1581 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
396 Participants
n=5 Participants
|
392 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
398 Participants
n=4 Participants
|
1581 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
341 participants
n=5 Participants
|
345 participants
n=7 Participants
|
334 participants
n=5 Participants
|
343 participants
n=4 Participants
|
1363 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
24 participants
n=5 Participants
|
27 participants
n=4 Participants
|
83 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
33 participants
n=5 Participants
|
27 participants
n=7 Participants
|
29 participants
n=5 Participants
|
21 participants
n=4 Participants
|
110 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
346 participants
n=5 Participants
|
344 participants
n=7 Participants
|
349 participants
n=5 Participants
|
352 participants
n=4 Participants
|
1391 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
50 participants
n=5 Participants
|
48 participants
n=7 Participants
|
46 participants
n=5 Participants
|
46 participants
n=4 Participants
|
190 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline to 28 weeksPopulation: Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.
For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms. For satisfying sexual events: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)
Outcome measures
| Measure |
Flibanserin 25 mg b.i.d
n=376 Participants
flibanserin: 25 mg twice daily
|
Flibanserin 50mg Qhs/b.i.d
n=369 Participants
flibanserin: 50 mg once at bedtime/twice daily
|
Flibanserin 50mg b.i.d./100mg Qhs
n=371 Participants
flibanserin: 50 mg twice daily/100 once at bedtime
|
Placebo
n=381 Participants
flibanserin: placebo
|
|---|---|---|---|---|
|
Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary.
|
1.4 SSEs per 28 days
Standard Deviation 3.5
|
1.4 SSEs per 28 days
Standard Deviation 3.4
|
1.9 SSEs per 28 days
Standard Deviation 5.3
|
1.1 SSEs per 28 days
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: baseline to 24 weeksPopulation: Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.
Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the 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" and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire: 0 = No desire 1. = Low desire 2. = Moderate desire 3. = Strong desire
Outcome measures
| Measure |
Flibanserin 25 mg b.i.d
n=376 Participants
flibanserin: 25 mg twice daily
|
Flibanserin 50mg Qhs/b.i.d
n=369 Participants
flibanserin: 50 mg once at bedtime/twice daily
|
Flibanserin 50mg b.i.d./100mg Qhs
n=371 Participants
flibanserin: 50 mg twice daily/100 once at bedtime
|
Placebo
n=381 Participants
flibanserin: placebo
|
|---|---|---|---|---|
|
Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question.
|
7.9 units on a scale
Standard Error 0.8
|
8.8 units on a scale
Standard Error 0.8
|
8.5 units on a scale
Standard Error 0.8
|
6.8 units on a scale
Standard Error 0.8
|
Adverse Events
Flibanserin 25 mg b.i.d
Serious events: 7 serious events
Other events: 168 other events
Deaths: 0 deaths
Flibanserin 50mg Qhs/b.i.d
Serious events: 6 serious events
Other events: 293 other events
Deaths: 0 deaths
Flibanserin 50mg b.i.d./100mg Qhs
Serious events: 3 serious events
Other events: 266 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 133 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flibanserin 25 mg b.i.d
n=396 participants at risk
flibanserin: 25 mg twice daily
|
Flibanserin 50mg Qhs/b.i.d
n=392 participants at risk
flibanserin: 50 mg once at bedtime/twice daily
|
Flibanserin 50mg b.i.d./100mg Qhs
n=395 participants at risk
flibanserin: 50 mg twice daily/100 once at bedtime
|
Placebo
n=398 participants at risk
flibanserin: placebo
|
|---|---|---|---|---|
|
Infections and infestations
appendicitis
|
0.25%
1/396 • Number of events 1
|
0.77%
3/392 • Number of events 3
|
0.00%
0/395
|
0.00%
0/398
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/396
|
0.00%
0/392
|
0.00%
0/395
|
0.25%
1/398 • Number of events 1
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/396
|
0.00%
0/392
|
0.00%
0/395
|
0.25%
1/398 • Number of events 1
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/396
|
0.00%
0/392
|
0.00%
0/395
|
0.25%
1/398 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitic acute
|
0.00%
0/396
|
0.26%
1/392 • Number of events 1
|
0.00%
0/395
|
0.00%
0/398
|
|
Hepatobiliary disorders
cholelithiasis
|
0.00%
0/396
|
0.26%
1/392 • Number of events 1
|
0.25%
1/395 • Number of events 1
|
0.75%
3/398 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/396
|
0.00%
0/392
|
0.25%
1/395 • Number of events 1
|
0.00%
0/398
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrustion
|
1.0%
4/396 • Number of events 4
|
0.26%
1/392 • Number of events 1
|
0.25%
1/395 • Number of events 1
|
0.00%
0/398
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.51%
2/396 • Number of events 2
|
0.00%
0/392
|
0.00%
0/395
|
0.50%
2/398 • Number of events 2
|
Other adverse events
| Measure |
Flibanserin 25 mg b.i.d
n=396 participants at risk
flibanserin: 25 mg twice daily
|
Flibanserin 50mg Qhs/b.i.d
n=392 participants at risk
flibanserin: 50 mg once at bedtime/twice daily
|
Flibanserin 50mg b.i.d./100mg Qhs
n=395 participants at risk
flibanserin: 50 mg twice daily/100 once at bedtime
|
Placebo
n=398 participants at risk
flibanserin: placebo
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
6.1%
24/396 • Number of events 25
|
5.1%
20/392 • Number of events 25
|
6.3%
25/395 • Number of events 30
|
5.0%
20/398 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
nasopharyngitis
|
5.1%
20/396 • Number of events 22
|
4.6%
18/392 • Number of events 20
|
4.1%
16/395 • Number of events 17
|
2.8%
11/398 • Number of events 13
|
|
Nervous system disorders
dizziness
|
5.6%
22/396 • Number of events 23
|
13.8%
54/392 • Number of events 65
|
12.2%
48/395 • Number of events 54
|
2.0%
8/398 • Number of events 8
|
|
Nervous system disorders
somnolence
|
7.3%
29/396 • Number of events 32
|
16.3%
64/392 • Number of events 73
|
11.9%
47/395 • Number of events 55
|
3.5%
14/398 • Number of events 14
|
|
General disorders
fatigue
|
6.1%
24/396 • Number of events 25
|
15.3%
60/392 • Number of events 64
|
9.6%
38/395 • Number of events 40
|
6.8%
27/398 • Number of events 29
|
|
Gastrointestinal disorders
nausea
|
5.1%
20/396 • Number of events 24
|
10.7%
42/392 • Number of events 51
|
11.9%
47/395 • Number of events 54
|
4.0%
16/398 • Number of events 18
|
|
Nervous system disorders
Headache
|
7.3%
29/396 • Number of events 37
|
8.9%
35/392 • Number of events 65
|
11.4%
45/395 • Number of events 68
|
9.3%
37/398 • Number of events 53
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place