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Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Noven Therapeutics
ClinicalTrials.gov Identifier:
NCT00786188
First received: November 4, 2008
Last updated: January 28, 2014
Last verified: January 2014
Results First Received: July 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Hot Flashes
Interventions: Drug: Brisdelle (paroxetine mesylate)
Drug: Sugar pill

  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
Recruitment Period = 29 October 2008 to 26 May 2009 Types of Locations = Research clinics

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug was administered once daily at bedtime.

Reporting Groups
  Description
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg

Interventions Administered:

Subjects received Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime.

Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime.

Placebo - Sugar Pill

Interventions Administered:

Subjects received placebo capsules administered once daily at bedtime.

Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive placebo administered once daily at bedtime.


Participant Flow:   Overall Study
    Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg     Placebo - Sugar Pill  
STARTED     50     52  
COMPLETED     45     51  
NOT COMPLETED     5     1  
Adverse Event                 3                 1  
Withdrawal by Subject                 2                 0  



  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
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Placebo - Sugar Pill Eligible subjects will be randomized to receive a sugar pill.
Total Total of all reporting groups

Baseline Measures
    Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg     Placebo - Sugar Pill     Total  
Number of Participants  
[units: participants]
  50     52     102  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     46     49     95  
>=65 years     4     3     7  
Age  
[units: years]
Mean ± Standard Deviation
  56  ± 55.8     55.0  ± 54.6     55.0  ± 55.1  
Gender  
[units: participants]
     
Female     50     52     102  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     50     52     102  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8   [ Time Frame: Week 4 and Week 8 ]

2.  Primary:   Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8   [ Time Frame: Week 4 and Week 8 ]

3.  Secondary:   Change From Baseline in Climacteric Symptoms at Week 8   [ Time Frame: Week 8 ]

4.  Secondary:   Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8   [ Time Frame: Week 4 and Week 8 ]

5.  Secondary:   Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8   [ Time Frame: Week 8 ]

6.  Secondary:   Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4   [ Time Frame: Week 4 ]

7.  Secondary:   Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4   [ Time Frame: Week 4 ]

8.  Secondary:   Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8   [ Time Frame: Week 4 and Week 8 ]

9.  Secondary:   Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8   [ Time Frame: Week 8 ]

10.  Secondary:   Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8   [ Time Frame: Week 4 and Week 8 ]

11.  Secondary:   Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8   [ Time Frame: Week 4 and Week 8 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sailaja Bhaskar, Executive Director, Clinical Research
Organization: Noven Therapeutics, LLC
phone: (212) 287-0798
e-mail: sbhaskar@noven.com


Publications:

Responsible Party: Noven Therapeutics
ClinicalTrials.gov Identifier: NCT00786188     History of Changes
Other Study ID Numbers: N30-002
Study First Received: November 4, 2008
Results First Received: July 16, 2013
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration