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Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

This study has been terminated.
(Study terminated for administrative reasons.)
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01057901
First received: January 25, 2010
Last updated: June 16, 2014
Last verified: June 2014
Results First Received: April 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Sexual Dysfunctions, Psychological
Interventions: Drug: Flibanserin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Flibanserin 100 mg

Flibanserin 100 mg administered at bedtime

Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks

Placebo

This is the matched placebo which will be administered two tablets daily at bedtime.

Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.


Participant Flow:   Overall Study
    Flibanserin 100 mg   Placebo
STARTED   376   372 
COMPLETED   116   126 
NOT COMPLETED   260   246 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Flibanserin 100 mg

Flibanserin 100 mg administered at bedtime

Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks

Placebo

This is the matched placebo which will be administered two tablets daily at bedtime.

Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.

Total Total of all reporting groups

Baseline Measures
   Flibanserin 100 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 376   372   748 
Age, Customized 
[Units: Participants]
     
less than 45 years   4   5   9 
45-54 years   154   128   282 
55-64   196   212   408 
65 years and older   22   27   49 
Gender 
[Units: Participants]
     
Female   376   372   748 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   324   310   634 
White Hispanic   18   27   45 
Black/African American   25   26   51 
Black/African American Hispanic   1   1   2 
Asian   8   4   12 
Asian Hispanic   0   0   0 
American Indian/Alaskan Native   0   2   2 
Hawaiian/Pacific Islander   0   2   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Number of Satisfying Sexual Events   [ Time Frame: baseline to 24 weeks ]

2.  Primary:   Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain   [ Time Frame: baseline to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Krista Barbour, Ph.D.
Organization: Sprout Pharmaceuticals
phone: 9198820850
e-mail: kbarbour@sproutpharma.com



Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01057901     History of Changes
Other Study ID Numbers: 511.156
Study First Received: January 25, 2010
Results First Received: April 14, 2014
Last Updated: June 16, 2014