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

Primary Purpose

Hot Flashes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brisdelle (paroxetine mesylate)
Placebo capsules
Sponsored by
Noven Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Vasomotor Symptoms, Menopause, Hot Flashes, Perimenopause, Nonhormonal therapies, Climacteric symptoms, Mesafem, Low-Dose Mesylate salt of Paroxetine (LDMP)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female, >40 years of age
  2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior
  3. Spontaneous amenorrhea for at least 12 consecutive months
  4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
  5. Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy

Exclusion Criteria:

  1. BMI ≥ 40 kg/m²
  2. Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
  3. History of self-injurious behavior
  4. History of clinical diagnosis of depression; or treatment for depression
  5. History of clinical diagnosis of borderline personality disorder
  6. Use of an investigational study medication within 30 days prior to screening or during the study
  7. Concurrent participation in another clinical trial or previous participation in this trial
  8. Family of investigational-site staff

Sites / Locations

  • Montgomery Women's Health Associates, PC
  • East Valley Family Physicians PLC
  • Genesis Center For Clinical Research
  • Apex Research Institute
  • Downtown Women's Health Care
  • Chase Medical Research, LLC
  • Visions Clinical Research
  • Meridien Research
  • Women's Medical Research Group, LLC
  • Altus Research
  • Anchor Research Center
  • Comprehensive Clinical Trials, LLC
  • Soapstone Center for Clinical Research
  • Mount Vernon Clinical Research, LLC
  • Women's Clinic of Lincoln, PC
  • Phoenix Ob-Gyn Associates, LLC
  • Rochester Clinical Research
  • Hawthorne Research
  • Hawthorne Medical Research, Inc.
  • Columbus Center for Women's Health Research
  • The Clinical Trial Center, LLC
  • Philadelphia Clinical Research
  • Clinical Trials Research Services, LLC
  • SC Clinical Research Center, LLC
  • Coastal Carolina Research Center
  • Chattanooga Medical Research, LLC
  • Clinical Research Associates, Inc.
  • The Woman's Hospital of Texas Clinical Research Center
  • Virginia Women's Center
  • National Clinical Research, Inc.
  • Women's Clinical Research Center
  • North Spokane Women's Clinic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brisdelle (paroxetine mesylate)

Placebo capsules

Arm Description

Brisdelle (paroxetine mesylate)

Sugar pill

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.
Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week. The results reported are: Mean Baseline frequency of moderate to severe VMS 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 12
Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12.
Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes

Secondary Outcome Measures

Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.
Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula: Percent reduction at week 24 = [(number of moderate to severe hot flash frequency at baseline - number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline ]*100%.
Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12.
Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median
Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes. The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline.
Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12.
Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.
Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.
Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median
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 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below.
Percentage of Responders
Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.
Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)
Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered). Responders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6.
Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median
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 at Week 4 and Week 12.
Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)
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 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question.
Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.
Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS) The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Responders: Subjects Achieving a Score of "Very Much Improved" Or "Much Improved" Or "Minimally Improved". Non Responders: Subjects with a Score of "No Change" Or "Minimally Worse" Or "Much Worse" Or "Very Much Worse".
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression
Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS). The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety. Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression). Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed). Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale. The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12.
Assessment of Mood
Mood was measured by 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 "325." Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below.
BMI Change From Baseline (kg/m2), Median
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. Assessment of the effect of Brisdelle compared with placebo on body mass index.

Full Information

First Posted
April 8, 2010
Last Updated
October 14, 2015
Sponsor
Noven Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01101841
Brief Title
24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
Official Title
A Phase 3, Twenty-Four Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noven Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
Detailed Description
The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg in subjects with moderate to severe postmenopausal VMS, defined as follows: Moderate VMS: Sensation of heat with sweating, able to continue activity Severe VMS: Sensation of heat with sweating, causing cessation of activity The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
Vasomotor Symptoms, Menopause, Hot Flashes, Perimenopause, Nonhormonal therapies, Climacteric symptoms, Mesafem, Low-Dose Mesylate salt of Paroxetine (LDMP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brisdelle (paroxetine mesylate)
Arm Type
Experimental
Arm Description
Brisdelle (paroxetine mesylate)
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm Description
Sugar pill
Intervention Type
Drug
Intervention Name(s)
Brisdelle (paroxetine mesylate)
Other Intervention Name(s)
Former Names: Mesafem Capsules or, LDMP (Low-Dose Mesylate salt of Paroxetine)
Intervention Description
Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Other Intervention Name(s)
Sugar pill
Intervention Description
Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.
Description
Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week. The results reported are: Mean Baseline frequency of moderate to severe VMS 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 12
Time Frame
Week 4 and Week 12
Title
Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12.
Description
Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes
Time Frame
Week 4 and Week 12
Secondary Outcome Measure Information:
Title
Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.
Description
Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula: Percent reduction at week 24 = [(number of moderate to severe hot flash frequency at baseline - number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline ]*100%.
Time Frame
Week 24
Title
Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median
Description
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12.
Time Frame
Week 4 and Week 12
Title
Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median
Description
Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes. The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline.
Time Frame
Week 4 and Week 12
Title
Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median
Description
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12.
Time Frame
Week 4 and Week 12
Title
Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median
Description
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.
Time Frame
Week 4 and Week 12
Title
Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median
Description
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.
Time Frame
Week 4 and Week 12
Title
Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median
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 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below.
Time Frame
Week 4 and Week 12
Title
Percentage of Responders
Description
Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.
Time Frame
Week 4 and Week 12
Title
Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)
Description
Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered). Responders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6.
Time Frame
Week 4 and Week 12
Title
Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median
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 at Week 4 and Week 12.
Time Frame
Week 4 and Week 12
Title
Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)
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 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question.
Time Frame
Week 4 and Week 12
Title
Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.
Description
Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS) The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Responders: Subjects Achieving a Score of "Very Much Improved" Or "Much Improved" Or "Minimally Improved". Non Responders: Subjects with a Score of "No Change" Or "Minimally Worse" Or "Much Worse" Or "Very Much Worse".
Time Frame
Week 4 and Week 12
Title
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression
Description
Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS). The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety. Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression). Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed). Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale. The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12.
Time Frame
Week 4 and Week 12
Title
Assessment of Mood
Description
Mood was measured by 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 "325." Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below.
Time Frame
Week 4 and Week 12
Title
BMI Change From Baseline (kg/m2), Median
Description
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. Assessment of the effect of Brisdelle compared with placebo on body mass index.
Time Frame
Week 4 and Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female, >40 years of age Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior Spontaneous amenorrhea for at least 12 consecutive months Amenorrhea for at least 6 months and meet the biochemical criteria for menopause Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy Exclusion Criteria: BMI ≥ 40 kg/m² Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS History of self-injurious behavior History of clinical diagnosis of depression; or treatment for depression History of clinical diagnosis of borderline personality disorder Use of an investigational study medication within 30 days prior to screening or during the study Concurrent participation in another clinical trial or previous participation in this trial Family of investigational-site staff
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derrick R Havin, MD
Organizational Affiliation
North Spokane Women's Clinic Research, Spokane, WA 99207
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard E Hedrick, MD
Organizational Affiliation
Hawthorne Medical Research, Inc., Winston-Salem, NC 27103
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel N Lederman, MD
Organizational Affiliation
Altus Research, Lake Worth, FL 33461
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larry S Seidman, DO
Organizational Affiliation
Philadelphia Clinical Research, LLC, Philadelphia, PA 19114
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James E Tomblin, MD
Organizational Affiliation
Hawthorne Medical Research, Inc., Greensboro, NC 27408
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter A Zedler, MD
Organizational Affiliation
Virginia Women's Center, Richmond, VA 23233
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
D S Harnsberger, MD
Organizational Affiliation
Chattanooga Medical Research, LLC, Chattanooga, TN 37404
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John A Hoekstra, MD
Organizational Affiliation
National Clinical Research, Inc., Richmond, VA 23294
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robin Kroll, MD
Organizational Affiliation
Women's Clinical Research Center, Seattle, WA 98105
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashley Tunkle, MD
Organizational Affiliation
Anchor Research Center, Naples, FL 34102
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Davis, MD
Organizational Affiliation
Rochester Clinical Research, Rochester, NY 14609
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donna DeSantis, MD
Organizational Affiliation
East Valley Family Physicians PLC, Chandler, AZ 85224
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Drosman
Organizational Affiliation
Genesis Center For Clinical Research, San Diego, CA 92103
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mildred Farmer, MD
Organizational Affiliation
Meridien Research, Brooksville, FL 34601
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Hurtado, MD
Organizational Affiliation
The Woman's Hospital of Texas Clinical Research Center, Houston, TX 77054
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Levine, MD
Organizational Affiliation
Phoenix Ob-Gyn Associates, LLC, Moorestown, NJ 08057
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tyrone Malloy, MD
Organizational Affiliation
Soapstone Center for Clinical Research, Decatur, GA 30034
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Ross, MD
Organizational Affiliation
Apex Research Institute, Santa Ana, CA 92705
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cynthia Strout, MD
Organizational Affiliation
Coastal Carolina Research Center, Mt. Pleasant, SC 29464
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arthur Waldbaum, MD
Organizational Affiliation
Downtown Women's Health Care, Denver, CO, 80218
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward Zbella, MD
Organizational Affiliation
Women's Medical Research Group, LLC, Clearwater, FL 33759
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James R Dockery, MD
Organizational Affiliation
Montgomery Women's Health Associates, PC, Montgomery, AL 36116
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen C Blank, MD
Organizational Affiliation
Mount Vernon Clinical Research, LLC, Sandy Springs, GA 30328
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith Aqua, MD
Organizational Affiliation
Visions Clinical Research, Boynton Beach, FL 33472
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saul R Berg, MD
Organizational Affiliation
Clinical Trials Research Services, LLC, Pittsburgh, PA 15206
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marvin Kalafer, MD
Organizational Affiliation
The Clinical Trial Center, LLC, Jenkintown, PA 19046
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David J Portman, MD
Organizational Affiliation
Columbus Center for Women's Health Research, Columbus, Ohio 43213
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Swanson, MD
Organizational Affiliation
Women's Clinic of Lincoln, PC, Lincoln, NE 68510
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Soufer, MD
Organizational Affiliation
Chase Medical Research, LLC, Waterbury, CT 06708
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ShaH R Scott, MD
Organizational Affiliation
Clinical Research Associates, Inc., Nashville, TN 37203
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary K Neuffer, MD
Organizational Affiliation
SC Clinical Research Center, LLC, Columbia, SC 29201
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald Ackerman, MD
Organizational Affiliation
Comprehensive Clinical Trials, LLC, West Palm Beach, FL 33409
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montgomery Women's Health Associates, PC
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
East Valley Family Physicians PLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Genesis Center For Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Apex Research Institute
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Downtown Women's Health Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Anchor Research Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Soapstone Center for Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Women's Clinic of Lincoln, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Phoenix Ob-Gyn Associates, LLC
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Hawthorne Research
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Columbus Center for Women's Health Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Philadelphia Clinical Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
SC Clinical Research Center, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Chattanooga Medical Research, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Woman's Hospital of Texas Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Virginia Women's Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
National Clinical Research, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Women's Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
North Spokane Women's Clinic Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15292498
Citation
Fugate SE, Church CO. Nonestrogen treatment modalities for vasomotor symptoms associated with menopause. Ann Pharmacother. 2004 Sep;38(9):1482-99. doi: 10.1345/aph.1D610. Epub 2004 Aug 3.
Results Reference
background
PubMed Identifier
11025867
Citation
Kritz-Silverstein D, Goldani Von Muhlen D, Barrett-Connor E. Prevalence and clustering of menopausal symptoms in older women by hysterectomy and oophorectomy status. J Womens Health Gend Based Med. 2000 Sep;9(7):747-55. doi: 10.1089/15246090050147727.
Results Reference
background
PubMed Identifier
16670414
Citation
Nelson HD, Vesco KK, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006 May 3;295(17):2057-71. doi: 10.1001/jama.295.17.2057.
Results Reference
background
PubMed Identifier
1003364
Citation
Greene JG. A factor analytic study of climacteric symptoms. J Psychosom Res. 1976;20(5):425-30. doi: 10.1016/0022-3999(76)90005-2. No abstract available.
Results Reference
background
PubMed Identifier
25137243
Citation
Pinkerton JV, Joffe H, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Low-dose paroxetine (7.5 mg) improves sleep in women with vasomotor symptoms associated with menopause. Menopause. 2015 Jan;22(1):50-8. doi: 10.1097/GME.0000000000000311.
Results Reference
derived
PubMed Identifier
24552977
Citation
Portman DJ, Kaunitz AM, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause. Menopause. 2014 Oct;21(10):1082-90. doi: 10.1097/GME.0000000000000210.
Results Reference
derived
PubMed Identifier
24045678
Citation
Simon JA, Portman DJ, Kaunitz AM, Mekonnen H, Kazempour K, Bhaskar S, Lippman J. Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. Menopause. 2013 Oct;20(10):1027-35. doi: 10.1097/GME.0b013e3182a66aa7.
Results Reference
derived
Links:
URL
http://www.noven.com
Description
Sponsor

Learn more about this trial

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

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