24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder

• ClinicalTrials.gov Identifier: NCT00360529
• Recruitment Status: Completed
• First Posted: August 4, 2006
• Results First Posted: June 27, 2016
• Last Update Posted: June 27, 2016
• Sponsor: Sprout Pharmaceuticals, Inc
• Information provided by (Responsible Party): Sprout Pharmaceuticals, Inc

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Sexual Dysfunctions, Psychological
• Intervention: Drug: flibanserin
• Enrollment: 880

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	Flibanserin 50 mg q.h.s.	Flibanserin 100 mg q.h.s
Arm/Group Description	placebo at bedtime	Flibanserin 50 mg at bedtime	Flibanserin 100 mg at bedtime
Period Title: Overall Study
Started	295	295	290
Completed	234	230	199
Not Completed	61	65	91
Reason Not Completed
Adverse Event	10	23	33
Protocol Violation	3	3	11
Lost to Follow-up	14	10	13
Withdrawal by Subject	22	14	18
Lack of Efficacy	8	6	5
Reason discontinued not explained above	4	9	11

Baseline Characteristics

Arm/Group Title		Placebo	Flibanserin 50 mg q.h.s.	Flibanserin 100 mg q.h.s	Total
Arm/Group Description		placebo at bedtime	Flibanserin 50 mg at bedtime	Flibanserin 100 mg at bedtime	Total of all reporting groups
Overall Number of Baseline Participants		295	295	290	880
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	295 participants	295 participants	290 participants	880 participants
		35.5 (7.0)	36.3 (7.5)	35.6 (7.2)	35.8 (7.2)
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	295 participants	295 participants	290 participants	880 participants
18 - 34 years		126	127	134	387
35 - 44 years		136	125	118	379
>= 45 years		33	43	38	114
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	295 participants	295 participants	290 participants	880 participants
	Female	295 100.0%	295 100.0%	290 100.0%	880 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	295 participants	295 participants	290 participants	880 participants
White		235	237	229	701
White Hispanic		21	26	19	66
Black Hispanic		2	1	1	4
Black		31	29	35	95
Asian		6	2	4	12
Asian Hispanic		0	0	1	1
Missing		0	0	1	1
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	295 participants	295 participants	290 participants	880 participants
Canada		66	69	66	201
United States		229	226	224	679
Marital Status; Measure Type: Number; Unit of measure: Participants	Number Analyzed	295 participants	295 participants	290 participants	880 participants
Unmarried		58	81	61	200
Married		237	214	229	680
Education level; Measure Type: Number; Unit of measure: Participants	Number Analyzed	295 participants	295 participants	290 participants	880 participants
Partial high school		1	6	3	10
High school graduate or equivalent		35	33	26	94
Partial college/university		78	80	85	243
College/university graduate		139	131	130	400
Post-graduate/professional degree		42	45	46	133
Missing		0	0	0	0
Employment status; Measure Type: Number; Unit of measure: Participants	Number Analyzed	295 participants	295 participants	290 participants	880 participants
Full time (>= 40 hours/week)		195	194	180	569
Part time (17-39 hours/week)		54	58	48	160
Occassional (1-16 hours/week)		5	8	15	28
Full time homemaker		33	28	31	92
Unemployed		8	7	16	31
Missing		0	0	0	0
How long in present relationship; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	295 participants	295 participants	290 participants	880 participants
		10.39 (6.50)	11.05 (6.94)	10.48 (6.38)	10.64 (6.61)
Alcohol status; Measure Type: Number; Unit of measure: Participants	Number Analyzed	295 participants	295 participants	290 participants	880 participants
Non drinker		68	83	78	229
Drinks - no interference		227	212	212	651
Drinks - possible interference		0	0	0	0
Smoking history; Measure Type: Number; Unit of measure: Participants	Number Analyzed	295 participants	295 participants	290 participants	880 participants
Never smoked		200	202	206	608
Ex-smoker		60	56	55	171
Currently smokes		35	37	29	101
Smoking history - pack years; Mean (Standard Deviation); Unit of measure: Pack years
	Number Analyzed	295 participants	295 participants	290 participants	880 participants
		6.72 (7.27)	6.46 (6.09)	6.07 (8.26)	6.43 (7.20)
Weight; Mean (Standard Deviation); Unit of measure: Kilograms
	Number Analyzed	295 participants	295 participants	290 participants	880 participants
		71.09 (15.31)	72.78 (17.05)	74.19 (17.53)	72.68 (16.68)
Body mass index; Mean (Standard Deviation); Unit of measure: Kilogram/square meter
	Number Analyzed	295 participants	295 participants	290 participants	880 participants
		26.35 (6.07)	26.90 (6.13)	27.04 (5.85)	26.76 (6.02)

Outcome Measures

1. Primary Outcome

Title	Satisfying Sexual Event Monthly Change From Baseline at Final Visit
Description	Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

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 FAS was analyzed for efficacy.

Arm/Group Title	Placebo	Flibanserin 50 mg q.h.s.	Flibanserin 100 mg q.h.s
Arm/Group Description:	placebo at bedtime	Flibanserin 50 mg at bedtime	Flibanserin 100 mg at bedtime
Overall Number of Participants Analyzed	285	291	275
Mean (Standard Deviation); Unit of Measure: number of events
	0.8 (3.4)	1.4 (3.6)	1.6 (3.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 50 mg q.h.s.
	Comments	Flibanserin 50 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0454
	Comments	Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 100 mg q.h.s
	Comments	Flibanserin 100 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0024
	Comments	Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

2. Primary Outcome

Title	Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit
Description	Change from baseline in eDiary Sexual Desire Monthly Total Score standardized to a 28-day period. Change from baseline calculated as the difference between the 4 week baseline period and Week 21 to Week 24. Patients recorded information daily throughout 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", scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire): 0 = No desire; = Low desire; = Moderate desire; = Strong desire Total score ranged from 0-84, with higher scores reflecting stronger desire). Monthly desire score was calculated as 28 x (sum of daily desire scores/number of responses).
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

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 FAS was analyzed for efficacy.

Arm/Group Title	Placebo	Flibanserin 50 mg q.h.s.	Flibanserin 100 mg q.h.s
Arm/Group Description:	placebo at bedtime	Flibanserin 50 mg at bedtime	Flibanserin 100 mg at bedtime
Overall Number of Participants Analyzed	285	291	275
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	6.9 (0.9)	8.2 (0.9)	9.1 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 50 mg q.h.s.
	Comments	Flibanserin 50 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2606
	Comments	Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1
	Method	ANCOVA
	Comments	Model includes treatment, centre and baseline as a covariate
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.3
	Confidence Interval	95%; -1.0 to 3.7
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 100 mg q.h.s
	Comments	Flibanserin 100 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.066
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Model includes treatment, centre and baseline as a covariate
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.2
	Confidence Interval	95%; -0.1 to 4.6
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit
Description	Change from baseline in the Female Sexual Distress Scale - revised (FSDS-R) Total Score with a seven day recall period. The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The maximum total score of the FSDS-R is '52' (score of minimum of 0 and maximum of 4 for each item) and indicates the maximum level of sexual distress (the higher the score, the higher the level of reported sexual desire).
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

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 FAS was analyzed for efficacy.

Arm/Group Title	Placebo	Flibanserin 50 mg q.h.s.	Flibanserin 100 mg q.h.s
Arm/Group Description:	placebo at bedtime	Flibanserin 50 mg at bedtime	Flibanserin 100 mg at bedtime
Overall Number of Participants Analyzed	289	293	280
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-4.9 (0.7)	-6.1 (0.7)	-8.9 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 50 mg q.h.s.
	Comments	Flibanserin 50 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1601
	Comments	Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1
	Method	ANCOVA
	Comments	Model includes treatment, centre and baseline as a covariate
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.2
	Confidence Interval	95%; -2.9 to 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 100 mg q.h.s
	Comments	Flibanserin 100 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1
	Method	ANCOVA
	Comments	Model includes treatment, centre and baseline as a covariate
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.9
	Confidence Interval	95%; -5.6 to -2.2
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit
Description	Change from baseline in the FSDS-R Question 13 (Bothered by low sexual desire). The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The scoring for item 13 is from 0-4, with 4 indicating the highest level of sexual distress.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

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 FAS was analyzed for efficacy.

Arm/Group Title	Placebo	Flibanserin 50 mg q.h.s.	Flibanserin 100 mg q.h.s
Arm/Group Description:	placebo at bedtime	Flibanserin 50 mg at bedtime	Flibanserin 100 mg at bedtime
Overall Number of Participants Analyzed	289	293	280
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-0.5 (0.1)	-0.6 (0.1)	-0.8 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 50 mg q.h.s.
	Comments	Flibanserin 50 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1144
	Comments	Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1
	Method	ANCOVA
	Comments	Model includes treatment, centre and baseline as a covariate
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	95%; -0.3 to 0.0
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 100 mg q.h.s
	Comments	Flibanserin 100 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1
	Method	ANCOVA
	Comments	Model includes treatment, centre and baseline as a covariate
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	95%; -0.5 to -0.2
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit
Description	Female Sexual Function Inventory (FSFI) Desire Domain assesses sexual desire or interest with 2 questions ranging from 1 (very low) to 5 (very high). The domain total score is multiplied by 0.6 yielding scores ranging from 1.2 to 6 (higher scores = higher level of desire or interest).
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

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 FAS was analyzed for efficacy.

Arm/Group Title	Placebo	Flibanserin 50 mg q.h.s.	Flibanserin 100 mg q.h.s
Arm/Group Description:	placebo at bedtime	Flibanserin 50 mg at bedtime	Flibanserin 100 mg at bedtime
Overall Number of Participants Analyzed	290	293	280
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	0.5 (0.1)	0.8 (0.1)	0.9 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 50 mg q.h.s.
	Comments	Flibanserin 50 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0173
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Model includes treatment, centre and baseline as a covariate
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.2
	Confidence Interval	95%; 0.0 to 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 100 mg q.h.s
	Comments	Flibanserin 100 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Model includes treatment, centre and baseline as a covariate
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.4
	Confidence Interval	95%; 0.2 to 0.5
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit
Description	The FSFI© is a self-administered questionnaire to assess FSD, which consists of 19 questions that are scored from '0' to '5.' The scale contains six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate higher levels of the domain assessed. The total score is a weighted average of the six domains, each contributing a maximum of 6 points to the total, so the minimum score is 2, while the maximum score of FSFI© is 36.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

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 FAS was analyzed for efficacy.

Arm/Group Title	Placebo	Flibanserin 50 mg q.h.s.	Flibanserin 100 mg q.h.s
Arm/Group Description:	placebo at bedtime	Flibanserin 50 mg at bedtime	Flibanserin 100 mg at bedtime
Overall Number of Participants Analyzed	289	292	280
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	2.4 (0.4)	3.9 (0.4)	5.0 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 50 mg q.h.s.
	Comments	Flibanserin 50 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0071
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Model includes treatment, centre and baseline as a covariate
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.5
	Confidence Interval	95%; 0.4 to 2.6
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 100 mg q.h.s
	Comments	Flibanserin 100 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Model includes treatment, centre and baseline as a covariate
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.5
	Confidence Interval	95%; 1.4 to 3.6
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Patient Benefit Evaluation
Description	The Patient Benefit Evaluation is a single question asking the patient whether or not she experienced a meaningful benefit from the study medication during the trial. This question ("Overall, do you believe that you have experienced a meaningful benefit from the study medication?") was asked upon treatment discontinuation.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

This question was asked at Week 24 only, so did not include participants who had discontinued the trial prior to that time (e.g., analysis population includes treatment completers only).

Arm/Group Title	Placebo	Flibanserin 50 mg q.h.s.	Flibanserin 100 mg q.h.s
Arm/Group Description:	placebo at bedtime	Flibanserin 50 mg at bedtime	Flibanserin 100 mg at bedtime
Overall Number of Participants Analyzed	266	271	254
Measure Type: Number; Unit of Measure: participants
Meaningful benefit from medication	71	94	98
No meaningful benefit from medication	195	177	156

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Flibanserin 25 mg bid versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0513
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Model includes treatment and centre
Method of Estimation	Estimation Parameter	Percentage responders
	Estimated Value	34.7
	Confidence Interval	95%; 29.0 to 40.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Flibanserin 50 mg q.h.s.
	Comments	Flibanserin 50 mg qhs versus placebo
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0059
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Model includes treatment and centre
Method of Estimation	Estimation Parameter	Percentage responders
	Estimated Value	38.6
	Confidence Interval	95%; 32.6 to 44.6
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo		Flibanserin 50 mg q.h.s.		Flibanserin 100 mg q.h.s
Arm/Group Description	placebo at bedtime		Flibanserin 50 mg at bedtime		Flibanserin 100 mg at bedtime
All-Cause Mortality
	Placebo		Flibanserin 50 mg q.h.s.		Flibanserin 100 mg q.h.s
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events
	Placebo		Flibanserin 50 mg q.h.s.		Flibanserin 100 mg q.h.s
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/295 (0.00%)		2/295 (0.68%)		3/290 (1.03%)
Gastrointestinal disorders
Crohn's disease † 1	0/295 (0.00%)	0	0/295 (0.00%)	0	1/290 (0.34%)	1
Large intestine perforation † 1	0/295 (0.00%)	0	0/295 (0.00%)	0	1/290 (0.34%)	1
Infections and infestations
Appendicitis † 1	0/295 (0.00%)	0	1/295 (0.34%)	1	0/290 (0.00%)	0
Gastroenteritis † 1	0/295 (0.00%)	0	1/295 (0.34%)	1	0/290 (0.00%)	0
Urinary tract infection † 1	0/295 (0.00%)	0	1/295 (0.34%)	1	0/290 (0.00%)	0
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder † 1	0/295 (0.00%)	0	0/295 (0.00%)	0	1/290 (0.34%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer † 1	0/295 (0.00%)	0	0/295 (0.00%)	0	1/290 (0.34%)	1
Metastases to lymph nodes † 1	0/295 (0.00%)	0	0/295 (0.00%)	0	1/290 (0.34%)	1
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA Version 11.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo		Flibanserin 50 mg q.h.s.		Flibanserin 100 mg q.h.s
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	87/295 (29.49%)		107/295 (36.27%)		135/290 (46.55%)
Gastrointestinal disorders
Nausea † 1	12/295 (4.07%)	12	23/295 (7.80%)	23	33/290 (11.38%)	33
General disorders
Fatigue † 1	8/295 (2.71%)	8	10/295 (3.39%)	10	18/290 (6.21%)	18
Infections and infestations
Nasopharyngitis † 1	24/295 (8.14%)	24	26/295 (8.81%)	26	18/290 (6.21%)	18
Sinusitis † 1	9/295 (3.05%)	9	7/295 (2.37%)	7	18/290 (6.21%)	18
Upper respiratory tract infection † 1	15/295 (5.08%)	15	22/295 (7.46%)	22	13/290 (4.48%)	13
Nervous system disorders
Dizziness † 1	5/295 (1.69%)	5	15/295 (5.08%)	15	26/290 (8.97%)	26
Headache † 1	27/295 (9.15%)	27	22/295 (7.46%)	27	22/290 (7.59%)	22
Somnolence † 1	9/295 (3.05%)	9	26/295 (8.81%)	26	32/290 (11.03%)	32
Psychiatric disorders
Insomnia † 1	16/295 (5.42%)	16	5/295 (1.69%)	5	21/290 (7.24%)	21
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA Version 11.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Any publication of the result of this trial must be consistent with the Sprout Pharmaceuticals publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract

Results Point of Contact

• Name/Title: Sprout Pharmaceuticals
• Organization: Sprout Pharmaceuticals
• Phone: 1-919-882-0850
• EMail: clinicaltrials@sproutpharma.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Derogatis LR, Komer L, Katz M, Moreau M, Kimura T, Garcia M Jr, Wunderlich G, Pyke R; VIOLET Trial Investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med. 2012 Apr;9(4):1074-85. doi: 10.1111/j.1743-6109.2011.02626.x. Epub 2012 Jan 16.

• Responsible Party: Sprout Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT00360529
• Other Study ID Numbers: 511.71; VIOLET ( Other Grant/Funding Number: Boehringer Ingelheim )
• First Submitted: August 3, 2006
• First Posted: August 4, 2006
• Results First Submitted: March 14, 2012
• Results First Posted: June 27, 2016
• Last Update Posted: June 27, 2016