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Trial record 1 of 2 for:    1003364 [PUBMED-IDS]
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Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause

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ClinicalTrials.gov Identifier: NCT00786188
Recruitment Status : Completed
First Posted : November 6, 2008
Results First Posted : March 12, 2014
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Noven Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Hot Flashes
Interventions Drug: Brisdelle (paroxetine mesylate)
Drug: Sugar pill
Enrollment 102
Recruitment Details Recruitment Period = 29 October 2008 to 26 May 2009 Types of Locations = Research clinics
Pre-assignment Details 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.
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg Placebo - Sugar Pill
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 50 52
Completed 45 51
Not Completed 5 1
Reason Not Completed
Adverse Event             3             1
Withdrawal by Subject             2             0
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg Placebo - Sugar Pill Total
Hide Arm/Group Description Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. Eligible subjects will be randomized to receive a sugar pill. Total of all reporting groups
Overall Number of Baseline Participants 50 52 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  92.0%
49
  94.2%
95
  93.1%
>=65 years
4
   8.0%
3
   5.8%
7
   6.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 52 participants 102 participants
56  (55.8) 55.0  (54.6) 55.0  (55.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 102 participants
Female
50
 100.0%
52
 100.0%
102
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 52 participants 102 participants
50 52 102
1.Primary Outcome
Title Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8
Hide Description

The number of hot flashes reported in the result table are:

  • Mean change in frequency of moderate to severe VMS from baseline to Week 4
  • Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week.
Time Frame Week 4 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MODIFIED ITT (MITT) POPULATION Brisdelle 49 (98.0%) Placebo 52 (100.0%) PER PROTOCOL (PP) POPULATION Brisdelle 45 (90.0%) Placebo 51(98.1%)
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg capsules.

Subjects will be randomized to one of the two treatments in a 1:1 ratio

Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 49 52
Mean (Standard Error)
Unit of Measure: Hot flashes
Baseline 82.44  (3.14) 83.18  (3.67)
Week 4 37.3  (3.11) 28.5  (3.30)
Week 8 42.2  (3.24) 35.5  (3.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brisdelle (Paroxetine Mesylate) Capsules, Placebo - Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0177
Comments Week 4 frequency
Method Repeated measures analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brisdelle (Paroxetine Mesylate) Capsules, Placebo - Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0541
Comments Week 8 frequency
Method Reapeated measures analysis
Comments [Not Specified]
2.Primary Outcome
Title Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8
Hide Description

A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity.

SS = (2•Fm + 3•Fs) ÷ (Fm + Fs)

Where:

SS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score.

Time Frame Week 4 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:
Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 48 51
Mean (Standard Error)
Unit of Measure: Severity score
Baseline 2.570  (0.044) 2.539  (0.035)
Week 4 0.128  (0.031) 0.072  (0.024)
Week 8 0.133  (0.032) 0.066  (0.026)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brisdelle (Paroxetine Mesylate) Capsules, Placebo - Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0644
Comments Week 4 severity
Method Reapeated measures analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brisdelle (Paroxetine Mesylate) Capsules, Placebo - Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0364
Comments Week 8 severity
Method Reapeated measures analysis
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Climacteric Symptoms at Week 8
Hide Description

The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.

The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.

The total GCS score ranges from "0" to "63" which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 8 were used to calculate change from baseline in these symptoms. The change from baseline is reported below.

Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.

Subjects will be randomized to one of the two treatments in a 1:1 ratio.

Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 47 51
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 16.63  (1.55) 17.33  (1.32)
Week 8 12.31  (9.24) 12.67  (6.90)
4.Secondary Outcome
Title Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8
Hide Description

A scale was not used for this measurement.

Composite scores of hot flashes were calculated by using the following formula:

CS = (2 • Fm + 3 • Fs)

Where:

CS = composite score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes recorded in the Run-In Period was used to calculate the baseline composite score.

Time Frame Week 4 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.

Subjects will be randomized to one of the two treatments in a 1:1 ratio.

Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 48 51
Mean (Standard Error)
Unit of Measure: Composite score
Baseline 211.9  (8.85) 213.0  (11.34)
Week 4 114.7  (8.43) 136.4  (9.01)
Week 8 102.6  (8.82) 119.2  (8.47)
5.Secondary Outcome
Title Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8
Hide Description

Depression & anxiety were measured using the Hospital Anxiety & Depression Scale (HADS).

The HADS is a scale developed to assess anxiety & depression. The HADS Scale consists of 14 Questions (7 relating to anxiety; 7 relating to depression) with possible scores ranging from 0 to 21.

The results presented below are the number of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression combined at Week 8.

Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.

Subjects will be randomized to one of the two treatments in a 1:1 ratio.

Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 44 50
Measure Type: Number
Unit of Measure: participants
Baseline 2 1
Week 4 0 1
Week 8 0 1
6.Secondary Outcome
Title Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4
Hide Description

Mood was measured using the Profile of Mood States (POMS) Questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from "65" to "335."

The percentage of participants who had a change from baseline in the total score at Week 4 is reported below.

Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.

Subjects will be randomized to one of the two treatments in a 1:1 ratio.

Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 48 49
Measure Type: Number
Unit of Measure: percentage of participants
21 18
7.Secondary Outcome
Title Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4
Hide Description

Interference of hot flashes was measured by using the Hot Flash-Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.

The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is define as a score ≤3 on each question.

Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.

Subjects will be randomized to one of the two treatments in a 1:1 ratio.

Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 46 47
Measure Type: Number
Unit of Measure: percentage of responders
12 11
8.Secondary Outcome
Title Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8
Hide Description The Clinical Global Impression Scale (CGIS) was completed by the investigator and was used to measure the severity of the VMS at any given time and the improvement from baseline. Responders were defined as subjects who achieved a score of 1 to 3 where 1 = very much improved, 2 = much improved, and 3 = minimally improved. Non-responders were defined as subjects who achieved a score of 4 to 7 where 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Time Frame Week 4 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.

Subjects will be randomized to one of the two treatments in a 1:1 ratio.

Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 46 50
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 73.91 60.00
Week 8 64.58 54.90
9.Secondary Outcome
Title Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8
Hide Description The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.

Subjects will be randomized to one of the two treatments in a 1:1 ratio.

Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 48 49
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 17.98  (0.67) 17.33  (0.72)
Week 8 18.00  (0.90) 18.15  (1.44)
10.Secondary Outcome
Title Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8
Hide Description

The Subject Impression Numerical Rating Scale (NRS) is an 11-point scale was used to measure how bothered a subject was by hot flashes both during the day and the night.

The measure being reported below is percentage of responders who had an improvement in NRS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is define as a score ≤3 on each question.

Time Frame Week 4 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.

Subjects will be randomized to one of the two treatments in a 1:1 ratio.

Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 48 49
Measure Type: Number
Unit of Measure: Percentage of true responders
Week 4 33.33 16.67
Week 8 37.14 21.95
11.Secondary Outcome
Title Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8
Hide Description Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.
Time Frame Week 4 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules Placebo - Sugar Pill
Hide Arm/Group Description:

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.

Subjects will be randomized to one of the two treatments in a 1:1 ratio.

Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
Overall Number of Participants Analyzed 48 51
Mean (Standard Error)
Unit of Measure: BMI Kg/m2
Baseline 27.85  (1.0) 27.69  (0.081)
Week 4 28.14  (1.01) 27.91  (0.84)
Week 8 27.73  (0.99) 28.04  (0.82)
Time Frame 56 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg Placebo - Sugar Pill
Hide Arm/Group Description Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. Eligible subjects will be randomized to receive a sugar pill.
All-Cause Mortality
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg Placebo - Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg Placebo - Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      1/52 (1.92%)    
Gastrointestinal disorders     
Colitis  1  0/49 (0.00%)  0 1/52 (1.92%)  1
Infections and infestations     
Clostridium difficile colitis  1  0/49 (0.00%)  0 1/52 (1.92%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg Placebo - Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/49 (53.06%)      26/52 (50.00%)    
Gastrointestinal disorders     
Nausea  1  2/49 (4.08%)  2 1/52 (1.92%)  1
General disorders     
Fatigue  1  4/49 (8.16%)  4 2/52 (3.85%)  2
Infections and infestations     
Nasopharyngitis  1  3/49 (6.12%)  3 4/52 (7.69%)  4
Sinusitis  1  0/49 (0.00%)  0 2/52 (3.85%)  2
Upper respiratory tract infection  1  4/49 (8.16%)  4 4/52 (7.69%)  4
Musculoskeletal and connective tissue disorders     
Myalgia  1  1/49 (2.04%)  1 2/52 (3.85%)  2
Pain in extremity  1  2/49 (4.08%)  2 1/52 (1.92%)  1
Nervous system disorders     
Headache  1  6/49 (12.24%)  6 5/52 (9.62%)  5
Psychiatric disorders     
Anxiety  1  3/49 (6.12%)  3 0/52 (0.00%)  0
Depression  1  2/49 (4.08%)  2 1/52 (1.92%)  1
Skin and subcutaneous tissue disorders     
Rash  1  0/49 (0.00%)  0 2/52 (3.85%)  2
Skin lesion  1  0/49 (0.00%)  0 2/52 (3.85%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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.
 
Results Point of Contact
Name/Title: Sailaja Bhaskar, Executive Director, Clinical Research
Organization: Noven Therapeutics, LLC
Phone: (212) 287-0798
Responsible Party: Noven Therapeutics
ClinicalTrials.gov Identifier: NCT00786188     History of Changes
Other Study ID Numbers: N30-002
First Submitted: November 4, 2008
First Posted: November 6, 2008
Results First Submitted: July 16, 2013
Results First Posted: March 12, 2014
Last Update Posted: October 15, 2015