Fixed 100 mg Every Evening of Flibanserin vs Placebo in P... | NCT00996164

Status Module

Label	Type	Description	Intervention Names
flibanserin 100 mg	Experimental	flibanserin 100mg po qd	Drug: Flibanserin
Placebo	Placebo Comparator	placebo 1 tab po qd	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Flibanserin	Drug	patients will be randomized to flibanserin or placebo in a double-blind manner	flibanserin 100 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.	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.	24 weeks
Change From Baseline in the SSE Count From Baseline to 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.	24 weeks

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
511.147.01074 Boehringer Ingelheim Investigational Site		Birmingham	Alabama		United States
511.147.01046 Boehringer Ingelheim Investigational Site

Results Section

Participant Flow Module

ID	Title	Description
FG000	Flibanserin 100 mg	flibanserin 100mg po qd
FG001	Placebo	placebo 1 tab po qd

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.

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.

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.

Posted

Mean

Standard Error

units on a scale

24 weeks

ID	Title	Description
OG000	Flibanserin 100 mg	flibanserin 100mg po qd Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner
OG001	Placebo	placebo 1 tab po qd Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner

Units	Counts
Participants	OG000506 OG001525

Title

Denominators

Categories

Title	Measurements
	OG0001.0± 0.1 OG0010.7± 0.1

Primary

Change From Baseline in the SSE Count From Baseline to 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.

Posted

Mean

Standard Deviation

SSEs

24 weeks

ID	Title	Description
OG000	Flibanserin 100 mg	flibanserin 100mg po qd Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner
OG001	Placebo

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
suicidal ideation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected543 at risk EG0011 events1 affected547 at risk
upper gastrointestinal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected543 at risk EG0011 events1 affected547 at risk
gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 events1 affected543 at risk EG0010 events0 affected547 at risk
asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected543 at risk EG0010 events0 affected547 at risk
biliary dyskinesia	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected543 at risk EG0010 events0 affected547 at risk
cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected543 at risk EG0010 events0 affected547 at risk
musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected543 at risk EG0010 events0 affected547 at risk
cervical vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected543 at risk EG0010 events0 affected547 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
somnolence	Nervous system disorders	Systematic Assessment	EG00081 events78 affected543 at risk EG00119 events19 affected547 at risk
dizziness	Nervous system disorders	Systematic Assessment	EG00062 events56 affected543 at risk EG0016 events6 affected547 at risk
nausea	Gastrointestinal disorders	Systematic Assessment	EG00044 events41 affected543 at risk EG00112 events12 affected547 at risk
fatigue	Nervous system disorders	Systematic Assessment	EG00032 events32 affected543 at risk EG00118 events18 affected547 at risk
upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00031 events30 affected543 at risk EG00114 events13 affected547 at risk

ID	Title	Description
BG000	Flibanserin 100 mg	flibanserin 100mg po qd
BG001	Placebo	placebo 1 tab po qd
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Flibanserin 100 mg	flibanserin 100mg po qd			4	543	237	543
EG001	Placebo	placebo 1 tab po qd			2	547	68	547