A Phase 2 interventional study of Brisdelle (paroxetine mesylate) and Sugar pill in Hot Flashes, sponsored by Noven Therapeutics. Completed at 10 sites in United States. Open to female participants aged 41 Years and older. Per ClinicalTrials.gov, last updated 2015-10-15.
Sponsored by Noven Therapeutics · Phase 2, Interventional, and Prevention
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:
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.
285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.
This study's enrollment of 102 is above the median of 90 across 255 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Noven Therapeutics is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Drug: Brisdelle (paroxetine mesylate)
Eligible subjects will be randomized to receive a sugar pill.
Drug: Sugar pill
Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg.
Also known as: Former Names: Mesafem capsules 7.5 mg or, LDMP (Low-Dose Mesylate salt of Paroxetine)
Subjects will receive a sugar pill.
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.
Time frame: Week 4 and Week 8
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.
Time frame: Week 4 and Week 8
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.
Time frame: Week 8
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.
Time frame: Week 4 and Week 8
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.
Time frame: 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.
Time frame: Week 4
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.
Time frame: Week 4
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.
Time frame: Week 4 and Week 8
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.
Time frame: Week 8
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.
Time frame: Week 4 and Week 8
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.
Time frame: Week 4 and Week 8
Recruitment Period = 29 October 2008 to 26 May 2009 Types of Locations = Research clinics
| Milestone | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Placebo - Sugar Pill |
|---|---|---|
| Started | 50 | 52 |
| Completed | 45 | 51 |
| Not completed | 5 | 1 |
| Withdrew: Adverse event | 3 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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.
| Hot flashes | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| 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 |
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.
| Severity score | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| 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 |
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.
| units on a scale | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| Baseline | 16.63 ± 1.55 | 17.33 ± 1.32 |
| Week 8 | 12.31 ± 9.24 | 12.67 ± 6.90 |
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.
| Composite score | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| 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 |
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.
| participants | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| Baseline | 2 | 1 |
| Week 4 | 0 | 1 |
| Week 8 | 0 | 1 |
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.
| percentage of participants | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4 | 21 | 18 |
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.
| percentage of responders | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4 | 12 | 11 |
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.
| Percentage of participants | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| Week 4 | 73.91 | 60.00 |
| Week 8 | 64.58 | 54.90 |
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.
| units on a scale | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| Baseline | 17.98 ± 0.67 | 17.33 ± 0.72 |
| Week 8 | 18.00 ± 0.90 | 18.15 ± 1.44 |
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.
| Percentage of true responders | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| Week 4 | 33.33 | 16.67 |
| Week 8 | 37.14 | 21.95 |
Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.
| BMI Kg/m2 | Brisdelle (Paroxetine Mesylate) Capsules | Placebo - Sugar Pill |
|---|---|---|
| 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 |
Collected over 56 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | — | 0/49 (0%) | 26/49 (53.1%) |
| Placebo - Sugar Pill | — | 1/52 (1.9%) | 26/52 (50%) |
| Event | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Placebo - Sugar Pill |
|---|---|---|
| ColitisGastrointestinal disorders | 0/49 | 1/52 |
| Clostridium difficile colitisInfections and infestations | 0/49 | 1/52 |
| Event | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Placebo - Sugar Pill |
|---|---|---|
| HeadacheNervous system disorders | 6/49 | 5/52 |
| FatigueGeneral disorders | 4/49 | 2/52 |
| Upper respiratory tract infectionInfections and infestations | 4/49 | 4/52 |
| NasopharyngitisInfections and infestations | 3/49 | 4/52 |
| AnxietyPsychiatric disorders | 3/49 | 0/52 |
| NauseaGastrointestinal disorders | 2/49 | 1/52 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 2/49 | 1/52 |
| DepressionPsychiatric disorders | 2/49 | 1/52 |
| SinusitisInfections and infestations | 0/49 | 2/52 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/49 | 2/52 |
| Age, Categorical(Participants) | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Placebo - Sugar Pill | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 46 | 49 | 95 |
| >=65 years | 4 | 3 | 7 |
| Age, Continuous(years) | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Placebo - Sugar Pill | Total |
|---|---|---|---|
| Mean | 56 ± 55.8 | 55.0 ± 54.6 | 55.0 ± 55.1 |
| Sex: Female, Male(Participants) | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Placebo - Sugar Pill | Total |
|---|---|---|---|
| Female | 50 | 52 | 102 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Placebo - Sugar Pill | Total |
|---|---|---|---|
| United States | 50 | 52 | 102 |
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