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Trial record 77 of 279 for:    Best Disease

Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

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ClinicalTrials.gov Identifier: NCT00360555
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
Interventions Drug: flibanserin
Drug: flibanserin 50mg
Drug: flibanserin 100mg
Drug: placebo
Enrollment 1584
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flibanserin 25 mg b.i.d Flibanserin 50mg Qhs/b.i.d Flibanserin 50mg b.i.d./100mg Qhs Placebo
Hide Arm/Group Description flibanserin: 25 mg twice daily flibanserin: 50 mg once at bedtime/twice daily flibanserin: 50 mg twice daily/100 once at bedtime flibanserin: placebo
Period Title: Overall Study
Started 396 393 396 399
Completed 274 259 251 287
Not Completed 122 134 145 112
Arm/Group Title Flibanserin 25 mg b.i.d Flibanserin 50mg Qhs/b.i.d Flibanserin 50mg b.i.d./100mg Qhs Placebo Total
Hide Arm/Group Description flibanserin: 25 mg twice daily flibanserin: 50 mg once at bedtime/twice daily flibanserin: 50 mg twice daily/100 once at bedtime flibanserin: placebo Total of all reporting groups
Overall Number of Baseline Participants 396 392 395 398 1581
Hide Baseline Analysis Population Description
Demographic data are available for participants who were included in the "treated" analysis population of 1,581 participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 392 participants 395 participants 398 participants 1581 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
396
 100.0%
392
 100.0%
395
 100.0%
398
 100.0%
1581
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 392 participants 395 participants 398 participants 1581 participants
Female
396
 100.0%
392
 100.0%
395
 100.0%
398
 100.0%
1581
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 396 participants 392 participants 395 participants 398 participants 1581 participants
White 341 345 334 343 1363
White Hispanic 16 16 24 27 83
Black Hispanic 1 0 0 1 2
Black 33 27 29 21 110
Asian 5 4 8 6 23
Asian Hispanic 0 0 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 396 participants 392 participants 395 participants 398 participants 1581 participants
United States 346 344 349 352 1391
Canada 50 48 46 46 190
1.Primary Outcome
Title Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary.
Hide Description

For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms.

For satisfying sexual events:

Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)

Time Frame baseline to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.
Arm/Group Title Flibanserin 25 mg b.i.d Flibanserin 50mg Qhs/b.i.d Flibanserin 50mg b.i.d./100mg Qhs Placebo
Hide Arm/Group Description:
flibanserin: 25 mg twice daily
flibanserin: 50 mg once at bedtime/twice daily
flibanserin: 50 mg twice daily/100 once at bedtime
flibanserin: placebo
Overall Number of Participants Analyzed 376 369 371 381
Mean (Standard Deviation)
Unit of Measure: SSEs per 28 days
1.4  (3.5) 1.4  (3.4) 1.9  (5.3) 1.1  (3.4)
2.Primary Outcome
Title Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question.
Hide Description

Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the 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” and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:

0 = No desire

  1. = Low desire
  2. = Moderate desire
  3. = Strong desire
Time Frame baseline to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.
Arm/Group Title Flibanserin 25 mg b.i.d Flibanserin 50mg Qhs/b.i.d Flibanserin 50mg b.i.d./100mg Qhs Placebo
Hide Arm/Group Description:
flibanserin: 25 mg twice daily
flibanserin: 50 mg once at bedtime/twice daily
flibanserin: 50 mg twice daily/100 once at bedtime
flibanserin: placebo
Overall Number of Participants Analyzed 376 369 371 381
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
7.9  (0.8) 8.8  (0.8) 8.5  (0.8) 6.8  (0.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flibanserin 25 mg b.i.d Flibanserin 50mg Qhs/b.i.d Flibanserin 50mg b.i.d./100mg Qhs Placebo
Hide Arm/Group Description flibanserin: 25 mg twice daily flibanserin: 50 mg once at bedtime/twice daily flibanserin: 50 mg twice daily/100 once at bedtime flibanserin: placebo
All-Cause Mortality
Flibanserin 25 mg b.i.d Flibanserin 50mg Qhs/b.i.d Flibanserin 50mg b.i.d./100mg Qhs Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Flibanserin 25 mg b.i.d Flibanserin 50mg Qhs/b.i.d Flibanserin 50mg b.i.d./100mg Qhs Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/396 (1.77%)      6/392 (1.53%)      3/395 (0.76%)      8/398 (2.01%)    
Hepatobiliary disorders         
Biliary colic   0/396 (0.00%)  0 0/392 (0.00%)  0 0/395 (0.00%)  0 1/398 (0.25%)  1
Cholecystitic acute   0/396 (0.00%)  0 1/392 (0.26%)  1 0/395 (0.00%)  0 0/398 (0.00%)  0
cholelithiasis   0/396 (0.00%)  0 1/392 (0.26%)  1 1/395 (0.25%)  1 3/398 (0.75%)  3
Infections and infestations         
appendicitis   1/396 (0.25%)  1 3/392 (0.77%)  3 0/395 (0.00%)  0 0/398 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Intervertebral disc degeneration   0/396 (0.00%)  0 0/392 (0.00%)  0 1/395 (0.25%)  1 0/398 (0.00%)  0
Intervertebral disc protrustion   4/396 (1.01%)  4 1/392 (0.26%)  1 1/395 (0.25%)  1 0/398 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast Cancer   0/396 (0.00%)  0 0/392 (0.00%)  0 0/395 (0.00%)  0 1/398 (0.25%)  1
Reproductive system and breast disorders         
Ovarian cyst   2/396 (0.51%)  2 0/392 (0.00%)  0 0/395 (0.00%)  0 2/398 (0.50%)  2
Vascular disorders         
Phlebitis superficial   0/396 (0.00%)  0 0/392 (0.00%)  0 0/395 (0.00%)  0 1/398 (0.25%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Flibanserin 25 mg b.i.d Flibanserin 50mg Qhs/b.i.d Flibanserin 50mg b.i.d./100mg Qhs Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   168/396 (42.42%)      293/392 (74.74%)      266/395 (67.34%)      133/398 (33.42%)    
Gastrointestinal disorders         
nausea   20/396 (5.05%)  24 42/392 (10.71%)  51 47/395 (11.90%)  54 16/398 (4.02%)  18
General disorders         
fatigue   24/396 (6.06%)  25 60/392 (15.31%)  64 38/395 (9.62%)  40 27/398 (6.78%)  29
Nervous system disorders         
dizziness   22/396 (5.56%)  23 54/392 (13.78%)  65 48/395 (12.15%)  54 8/398 (2.01%)  8
somnolence   29/396 (7.32%)  32 64/392 (16.33%)  73 47/395 (11.90%)  55 14/398 (3.52%)  14
Headache   29/396 (7.32%)  37 35/392 (8.93%)  65 45/395 (11.39%)  68 37/398 (9.30%)  53
Respiratory, thoracic and mediastinal disorders         
upper respiratory infection   24/396 (6.06%)  25 20/392 (5.10%)  25 25/395 (6.33%)  30 20/398 (5.03%)  21
nasopharyngitis   20/396 (5.05%)  22 18/392 (4.59%)  20 16/395 (4.05%)  17 11/398 (2.76%)  13
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Scientific Program Director
Organization: Sprout Pharmaceuticals
Phone: 9198820850
Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00360555     History of Changes
Other Study ID Numbers: 511.75
First Submitted: August 3, 2006
First Posted: August 4, 2006
Results First Submitted: March 27, 2014
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016