Trial Outcomes & Findings for Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America (NCT NCT01057901)

Last Updated: 2014-06-17

Results Overview

The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

748 participants

Primary outcome timeframe

baseline to 24 weeks

Results posted on

2014-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Flibanserin 100 mg Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks	Placebo This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.
Overall Study STARTED	376	372
Overall Study COMPLETED	116	126
Overall Study NOT COMPLETED	260	246

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flibanserin 100 mg n=376 Participants Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks	Placebo n=372 Participants This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.	Total n=748 Participants Total of all reporting groups
Age, Customized less than 45 years	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Age, Customized 45-54 years	154 participants n=5 Participants	128 participants n=7 Participants	282 participants n=5 Participants
Age, Customized 55-64	196 participants n=5 Participants	212 participants n=7 Participants	408 participants n=5 Participants
Age, Customized 65 years and older	22 participants n=5 Participants	27 participants n=7 Participants	49 participants n=5 Participants
Sex: Female, Male Female	376 Participants n=5 Participants	372 Participants n=7 Participants	748 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	324 participants n=5 Participants	310 participants n=7 Participants	634 participants n=5 Participants
Race/Ethnicity, Customized White Hispanic	18 participants n=5 Participants	27 participants n=7 Participants	45 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	25 participants n=5 Participants	26 participants n=7 Participants	51 participants n=5 Participants
Race/Ethnicity, Customized Black/African American Hispanic	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	8 participants n=5 Participants	4 participants n=7 Participants	12 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	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Hawaiian/Pacific Islander	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 24 weeks

Population: 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 usable data.

Outcome measures

Outcome measures
Measure	Flibanserin 100 mg n=346 Participants Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks	Placebo n=335 Participants This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.
Change From Baseline in the Number of Satisfying Sexual Events	1.0 SSEs/month Standard Deviation 3.3	0.7 SSEs/month Standard Deviation 2.9

PRIMARY outcome

Timeframe: baseline to 24 weeks

The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains 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 (1 is lowest level of desire and 5 is the highest level of desire). 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 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.

Outcome measures

Outcome measures
Measure	Flibanserin 100 mg n=351 Participants Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks	Placebo n=343 Participants This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain	0.6 units on a scale Standard Error 0.1	0.4 units on a scale Standard Error 0.1

Adverse Events

Flibanserin 100 mg

Serious events: 6 serious events

Other events: 118 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flibanserin 100 mg n=376 participants at risk Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks	Placebo n=369 participants at risk This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.
Infections and infestations Diverticulitis	0.00% 0/376 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	0.27% 1/369 • Number of events 1 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Infections and infestations Gastroenteritis viral	0.27% 1/376 • Number of events 1 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	0.00% 0/369 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer in situ	0.27% 1/376 • Number of events 1 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	0.00% 0/369 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Nervous system disorders Transient ischemic event	0.00% 0/376 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	0.27% 1/369 • Number of events 1 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Investigations Liver function test abnormal	0.27% 1/376 • Number of events 1 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	0.00% 0/369 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Injury, poisoning and procedural complications Fall	0.00% 0/376 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	0.27% 1/369 • Number of events 1 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Injury, poisoning and procedural complications hip fracture	0.00% 0/376 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	0.27% 1/369 • Number of events 1 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Injury, poisoning and procedural complications meniscus lesion	0.27% 1/376 • Number of events 1 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	0.00% 0/369 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Injury, poisoning and procedural complications road traffic accident	0.27% 1/376 • Number of events 1 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	0.00% 0/369 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Injury, poisoning and procedural complications tibia fracture	0.27% 1/376 • Number of events 1 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	0.00% 0/369 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.

Other adverse events

Other adverse events
Measure	Flibanserin 100 mg n=376 participants at risk Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks	Placebo n=369 participants at risk This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.
Psychiatric disorders Insomnia	7.7% 29/376 • Number of events 30 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	3.8% 14/369 • Number of events 14 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Nervous system disorders somnolence	6.9% 26/376 • Number of events 27 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	2.2% 8/369 • Number of events 9 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Nervous system disorders headache	5.1% 19/376 • Number of events 21 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	6.5% 24/369 • Number of events 27 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Nervous system disorders dizziness	6.4% 24/376 • Number of events 28 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	3.5% 13/369 • Number of events 14 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Gastrointestinal disorders nausea	5.3% 20/376 • Number of events 21 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.	4.1% 15/369 • Number of events 15 Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.

Additional Information

Krista Barbour, Ph.D.

Sprout Pharmaceuticals

Phone: 9198820850

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place