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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Flibanserin 50 mg q.h.s. Flibanserin 100 mg q.h.s
Hide 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
Arm/Group Title Placebo Flibanserin 50 mg q.h.s. Flibanserin 100 mg q.h.s Total
Hide 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
Hide 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)
1.Primary Outcome
Title Satisfying Sexual Event Monthly Change From Baseline at Final Visit
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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

  1. = Low desire
  2. = Moderate desire
  3. = 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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]
Hide 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]
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
Hide 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   --/--      --/--      --/--    
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Sprout Pharmaceuticals
Organization: Sprout Pharmaceuticals
Phone: 1-919-882-0850
EMail: clinicaltrials@sproutpharma.com
Layout table for additonal information
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