Trial Outcomes & Findings for Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder (NCT NCT00996164)

Last Updated: 2014-05-19

Results Overview

The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 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 on the desire domain, the higher the level of reported sexual desire.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1090 participants

Primary outcome timeframe

24 weeks

Results posted on

2014-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Flibanserin 100 mg flibanserin 100mg po qd	Placebo placebo 1 tab po qd
Overall Study STARTED	543	547
Overall Study COMPLETED	408	446
Overall Study NOT COMPLETED	135	101

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flibanserin 100 mg n=543 Participants flibanserin 100mg po qd	Placebo n=547 Participants placebo 1 tab po qd	Total n=1090 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
Age, Categorical Between 18 and 65 years	543 Participants n=5 Participants	547 Participants n=7 Participants	1090 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.5 years STANDARD_DEVIATION 7.8 • n=5 Participants	36.6 years STANDARD_DEVIATION 8.0 • n=7 Participants	36.5 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	543 Participants n=5 Participants	547 Participants n=7 Participants	1090 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	543 participants n=5 Participants	547 participants n=7 Participants	1090 participants n=5 Participants

PRIMARY outcome

Timeframe: 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, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.

Outcome measures

Outcome measures
Measure	Flibanserin 100 mg n=506 Participants flibanserin 100mg po qd Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner	Placebo n=525 Participants placebo 1 tab po qd Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner
The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.	1.0 units on a scale Standard Error 0.1	0.7 units on a scale Standard Error 0.1

PRIMARY outcome

Timeframe: 24 weeks

The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The 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. An eDiary was used by the 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 entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.

Outcome measures

Outcome measures
Measure	Flibanserin 100 mg n=500 Participants flibanserin 100mg po qd Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner	Placebo n=521 Participants placebo 1 tab po qd Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner
Change From Baseline in the SSE Count From Baseline to 24 Weeks	2.5 SSEs Standard Deviation 4.6	1.5 SSEs Standard Deviation 4.5

Adverse Events

Flibanserin 100 mg

Serious events: 4 serious events

Other events: 237 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flibanserin 100 mg n=543 participants at risk flibanserin 100mg po qd	Placebo n=547 participants at risk placebo 1 tab po qd
Psychiatric disorders suicidal ideation	0.00% 0/543	0.18% 1/547 • Number of events 1
Gastrointestinal disorders upper gastrointestinal hemorrhage	0.00% 0/543	0.18% 1/547 • Number of events 1
Infections and infestations gastroenteritis	0.18% 1/543 • Number of events 1	0.00% 0/547
Respiratory, thoracic and mediastinal disorders asthma	0.18% 1/543 • Number of events 1	0.00% 0/547
Hepatobiliary disorders biliary dyskinesia	0.18% 1/543 • Number of events 1	0.00% 0/547
Hepatobiliary disorders cholelithiasis	0.18% 1/543 • Number of events 1	0.00% 0/547
Musculoskeletal and connective tissue disorders musculoskeletal chest pain	0.18% 1/543 • Number of events 1	0.00% 0/547
Injury, poisoning and procedural complications cervical vertebral fracture	0.18% 1/543 • Number of events 1	0.00% 0/547

Other adverse events

Other adverse events
Measure	Flibanserin 100 mg n=543 participants at risk flibanserin 100mg po qd	Placebo n=547 participants at risk placebo 1 tab po qd
Nervous system disorders somnolence	14.4% 78/543 • Number of events 81	3.5% 19/547 • Number of events 19
Nervous system disorders dizziness	10.3% 56/543 • Number of events 62	1.1% 6/547 • Number of events 6
Gastrointestinal disorders nausea	7.6% 41/543 • Number of events 44	2.2% 12/547 • Number of events 12
Nervous system disorders fatigue	5.9% 32/543 • Number of events 32	3.3% 18/547 • Number of events 18
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	5.5% 30/543 • Number of events 31	2.4% 13/547 • Number of events 14

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