Back to resultsEight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Primary Purpose
Hot Flashes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brisdelle (paroxetine mesylate)
Sugar pill
Sponsored by
About this trial
This is an interventional prevention trial for Hot Flashes focused on measuring Menopause, Vasomotor Symptoms, Hot flash, Perimenopause, Nonhormonal therapies, Climacteric symptoms, Mesafem, Low-Dose Mesylate salt of Paroxetine (LDMP)
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:
- History of hypersensitivity or adverse reaction to paroxetine mesylate
- 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
Sites / Locations
- Altus Research
- Anchor Research Center
- Hawthorne Research
- Hawthorne Medical Research, Inc.
- Philadelphia Clinical Research
- Chattanooga Medical Research, LLC
- 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 - Sugar Pill
Arm 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.
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8
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.
Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8
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.
Secondary Outcome Measures
Change From Baseline in Climacteric Symptoms at Week 8
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.
Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8
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.
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8
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.
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4
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.
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4
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.
Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8
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.
Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8
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.
Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8
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.
Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8
Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00786188
Brief Title
Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Official Title
A Phase 2, Exploratory, Eight-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
November 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (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
This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (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
Detailed Description
Eligible subjects will be entered into a 1-week observation period followed by a 1-week run-in period. Following completion of the run-in period, eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug will be administered once daily at bedtime. Symptom assessment questionnaires will be administered at baseline and at Day 28 and Day 57 visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
Menopause, Vasomotor Symptoms, Hot flash, Perimenopause, Nonhormonal therapies, Climacteric symptoms, Mesafem, Low-Dose Mesylate salt of Paroxetine (LDMP)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brisdelle (paroxetine mesylate)
Arm Type
Experimental
Arm Description
Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Arm Title
Placebo - Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Eligible subjects will be randomized to receive a sugar pill.
Intervention Type
Drug
Intervention Name(s)
Brisdelle (paroxetine mesylate)
Other Intervention Name(s)
Former Names: Mesafem capsules 7.5 mg or, LDMP (Low-Dose Mesylate salt of Paroxetine)
Intervention Description
Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg.
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Intervention Description
Subjects will receive a sugar pill.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8
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
Title
Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Climacteric Symptoms at Week 8
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
Title
Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8
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
Title
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8
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
Title
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4
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
Title
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4
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
Title
Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8
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
Title
Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8
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
Title
Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8
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
Title
Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8
Description
Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.
Time Frame
Week 4 and Week 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
41 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:
History of hypersensitivity or adverse reaction to paroxetine mesylate
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
Patrick F. Freuen, MD
Organizational Affiliation
North Spokane Women's Clinic, 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
Facility Information:
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
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
Philadelphia Clinical Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Chattanooga Medical Research, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
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
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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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