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A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal 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: NCT01103362
Recruitment Status : Terminated (administrative reasons)
First Posted : April 14, 2010
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sexual Dysfunctions, Psychological
Intervention Drug: flibanserin
Enrollment 596
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flibanserin 100mg
Hide Arm/Group Description

flibanserin 100mg po qd

flibanserin: all patients will receive open-label flibanserin 100mg

Period Title: Overall Study
Started 596
Completed 0
Not Completed 596
Reason Not Completed
study terminated             596
Arm/Group Title Flibanserin 100mg
Hide Arm/Group Description

flibanserin 100mg po qd

flibanserin: all patients will receive open-label flibanserin 100mg

Overall Number of Baseline Participants 596
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
age Number Analyzed 596 participants
45.7  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 596 participants
Female
596
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 596 participants
White 473
White Hispanic 53
Black/African American 53
Black/African American Hispanic 1
Asian 7
American Indian/Alaskan Native 7
Hawaiian/Pacific Islander 2
1.Primary Outcome
Title The Frequency of Adverse Events
Hide Description [Not Specified]
Time Frame A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flibanserin 100mg
Hide Arm/Group Description:

flibanserin 100mg po qd

flibanserin: all patients will receive open-label flibanserin 100mg

Overall Number of Participants Analyzed 596
Measure Type: Number
Unit of Measure: percentage of patients-any adverse event
59.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flibanserin 100mg
Hide Arm/Group Description

flibanserin 100mg po qd

flibanserin: all patients will receive open-label flibanserin 100mg

All-Cause Mortality
Flibanserin 100mg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Flibanserin 100mg
Affected / at Risk (%) # Events
Total   4/596 (0.67%)    
Gastrointestinal disorders   
Irritable Bowel Syndrome   1/596 (0.17%)  1
Infections and infestations   
Cellulitis   1/596 (0.17%)  1
Injury, poisoning and procedural complications   
Animal Bite   1/596 (0.17%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal Cell Carcinoma   1/596 (0.17%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Flibanserin 100mg
Affected / at Risk (%) # Events
Total   170/596 (28.52%)    
Gastrointestinal disorders   
Nausea   32/596 (5.37%)  35
Nervous system disorders   
Dizziness   57/596 (9.56%)  63
somnolence   47/596 (7.89%)  49
Psychiatric disorders   
Insomnia   34/596 (5.70%)  34
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
Layout table for Results Point of Contact information
Name/Title: Krista Barbour, Ph.D.
Organization: Sprout Pharmaceuticals
Phone: 9198820850
EMail: kbarbour@sproutpharma.com
Layout table for additonal information
Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01103362    
Other Study ID Numbers: 511.133
First Submitted: April 13, 2010
First Posted: April 14, 2010
Results First Submitted: April 11, 2014
Results First Posted: May 12, 2014
Last Update Posted: May 12, 2014