Trial Outcomes & Findings for Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women (NCT NCT00996372)
NCT ID: NCT00996372
Last Updated: 2014-06-12
Results Overview
A small handheld electronic device (eDiary) was used by 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 could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.
COMPLETED
PHASE3
949 participants
baseline through 24 weeks
2014-06-12
Participant Flow
Participant milestones
| Measure |
Flibanserin 100mg
flibanserin 100mg po qd
flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner
|
Placebo
placebo one tablet po qd
placebo : patients will be randomized to flibanserin or placebo in a double-blind manner
|
|---|---|---|
|
Overall Study
STARTED
|
468
|
481
|
|
Overall Study
COMPLETED
|
365
|
397
|
|
Overall Study
NOT COMPLETED
|
103
|
84
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Flibanserin
n=468 Participants
|
Placebo
n=481 Participants
|
Total
n=949 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
less than 45 years
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Age, Customized
45-54 years
|
192 participants
n=5 Participants
|
213 participants
n=7 Participants
|
405 participants
n=5 Participants
|
|
Age, Customized
55-64
|
248 participants
n=5 Participants
|
237 participants
n=7 Participants
|
485 participants
n=5 Participants
|
|
Age, Customized
65 years and older
|
20 participants
n=5 Participants
|
25 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
468 Participants
n=5 Participants
|
481 Participants
n=7 Participants
|
949 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
398 participants
n=5 Participants
|
422 participants
n=7 Participants
|
820 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
28 participants
n=5 Participants
|
23 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
35 participants
n=5 Participants
|
27 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hawaiian/Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline through 24 weeksPopulation: The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.
A small handheld electronic device (eDiary) was used by 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 could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.
Outcome measures
| Measure |
Flibanserin 100mg
n=429 Participants
flibanserin 100mg po qd
flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner
|
Placebo
n=462 Participants
placebo one tablet po qd
placebo : patients will be randomized to flibanserin or placebo in a double-blind manner
|
|---|---|---|
|
Change From Baseline in the Number of Satisfying Sexual Events
|
1.0 sexual events
Standard Deviation 2.9
|
0.6 sexual events
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: baseline through 24 weeksPopulation: The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.
The FSFI© is a brief, self-administered questionnaire to assess key dimensions of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (with 1 being the lowest report of desire and 5 being the highest). The raw scores of the two 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, the higher the reported level of desire).
Outcome measures
| Measure |
Flibanserin 100mg
n=432 Participants
flibanserin 100mg po qd
flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner
|
Placebo
n=463 Participants
placebo one tablet po qd
placebo : patients will be randomized to flibanserin or placebo in a double-blind manner
|
|---|---|---|
|
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
|
0.7 units on a scale
Standard Deviation 0.1
|
0.4 units on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: change from baseline to 24 weeksPopulation: The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.
The FSDS© is a self-administered measure of female personal distress associated with sexual dysfunction. Question 13 inquires about distress specifically related to sexual desire. The range for each question, including Question 13, is 0 (Never) to 4 (Always).
Outcome measures
| Measure |
Flibanserin 100mg
n=432 Participants
flibanserin 100mg po qd
flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner
|
Placebo
n=462 Participants
placebo one tablet po qd
placebo : patients will be randomized to flibanserin or placebo in a double-blind manner
|
|---|---|---|
|
Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R)
|
-0.8 units on a scale
Standard Error 0.1
|
-0.6 units on a scale
Standard Error 0.1
|
Adverse Events
Flibanserin 100mg
Placebo
Serious adverse events
| Measure |
Flibanserin 100mg
n=468 participants at risk
flibanserin 100mg po qd
flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner
|
Placebo
n=481 participants at risk
placebo one tablet po qd
placebo : patients will be randomized to flibanserin or placebo in a double-blind manner
|
|---|---|---|
|
Metabolism and nutrition disorders
diabetes mellitus inadequate control
|
0.00%
0/468
|
0.21%
1/481 • Number of events 1
|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.00%
0/468
|
0.21%
1/481 • Number of events 1
|
|
Injury, poisoning and procedural complications
wrist fracture
|
0.00%
0/468
|
0.21%
1/481 • Number of events 1
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/468
|
0.21%
1/481 • Number of events 1
|
|
Infections and infestations
dengue fever
|
0.21%
1/468 • Number of events 1
|
0.00%
0/481
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
chronic lymphocytic leukemia
|
0.21%
1/468 • Number of events 1
|
0.00%
0/481
|
|
Nervous system disorders
intraventricular hemorrhage
|
0.21%
1/468 • Number of events 1
|
0.00%
0/481
|
|
Cardiac disorders
myocardial infarction
|
0.21%
1/468 • Number of events 1
|
0.00%
0/481
|
|
Gastrointestinal disorders
pancreatitis
|
0.21%
1/468 • Number of events 1
|
0.00%
0/481
|
|
Gastrointestinal disorders
duodenitis
|
0.21%
1/468 • Number of events 1
|
0.00%
0/481
|
|
Gastrointestinal disorders
hematemesis
|
0.21%
1/468 • Number of events 1
|
0.00%
0/481
|
|
Gastrointestinal disorders
hepatic enzyme increased
|
0.21%
1/468 • Number of events 1
|
0.00%
0/481
|
Other adverse events
| Measure |
Flibanserin 100mg
n=468 participants at risk
flibanserin 100mg po qd
flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner
|
Placebo
n=481 participants at risk
placebo one tablet po qd
placebo : patients will be randomized to flibanserin or placebo in a double-blind manner
|
|---|---|---|
|
Nervous system disorders
dizziness
|
9.8%
46/468 • Number of events 54
|
3.1%
15/481 • Number of events 15
|
|
Nervous system disorders
somnolence
|
8.8%
41/468 • Number of events 44
|
1.5%
7/481 • Number of events 8
|
|
Nervous system disorders
headache
|
6.0%
28/468 • Number of events 29
|
4.8%
23/481 • Number of events 23
|
|
Gastrointestinal disorders
nausea
|
7.5%
35/468 • Number of events 37
|
3.5%
17/481 • Number of events 18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60