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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Sexual Dysfunctions, Psychological
Interventions: Drug: Flibanserin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


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
Health Authority: Canada: Health Canada
United States: Food and Drug Administration