Hot FlashesPhase 2NCT00786188
Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
A Phase 2 study testing Brisdelle (paroxetine mesylate) and Sugar pill in people with Hot Flashes, run by Noven Therapeutics at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 41 years and older, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Brisdelle (paroxetine mesylate) and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404
Hawthorne Research
Greensboro, North Carolina, 27408
Altus Research
Lake Worth, Florida, 33461
Anchor Research Center
Naples, Florida, 34102
Philadelphia Clinical Research
Philadelphia, Pennsylvania, 19114
Virginia Women's Center
Richmond, Virginia, 23233
National Clinical Research, Inc.
Richmond, Virginia, 23294
Women's Clinical Research Center
Seattle, Washington, 98105
North Spokane Women's Clinic Research
Spokane, Washington, 99207
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103
About this study
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
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
Read the 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.
- Conditions
- Hot Flashes
- Being tested
- Brisdelle (paroxetine mesylate), Sugar pill
- Keywords
- Menopause, Vasomotor Symptoms, Hot flash, Perimenopause, Nonhormonal therapies, Climacteric symptoms, Mesafem, Low-Dose Mesylate salt of Paroxetine (LDMP)
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brisdelle (paroxetine mesylate)Drug
Also called Former Names: Mesafem capsules 7.5 mg or, LDMP (Low-Dose Mesylate salt of Paroxetine)
Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg.
Sugar pillDrug
Subjects will receive a sugar pill.
| Study group | Role | What they receive |
|---|---|---|
| Brisdelle (paroxetine mesylate) | Experimental | Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. Receives: Drug: Brisdelle (paroxetine mesylate) |
| Placebo - Sugar Pill | Placebo comparator | Eligible subjects will be randomized to receive a sugar pill. Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 4 and Week 8
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noven Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick F. Freuen, MD, Principal investigator, North Spokane Women's Clinic, Spokane, WA 99207Richard E. Hedrick, MD, Principal investigator, Hawthorne Medical Research, Inc., Winston-Salem, NC 27103Samuel N. Lederman, MD, Principal investigator, Altus Research, Lake Worth, FL 33461Larry S. Seidman, DO, Principal investigator, Philadelphia Clinical Research, LLC, Philadelphia, PA 19114James E. Tomblin, MD, Principal investigator, Hawthorne Medical Research, Inc., Greensboro, NC 27408Peter A. Zedler, MD, Principal investigator, Virginia Women's Center, Richmond, VA 23233D. S. Harnsberger, MD, Principal investigator, Chattanooga Medical Research, LLC, Chattanooga, TN 37404John A. Hoekstra, MD, Principal investigator, National Clinical Research, Inc., Richmond, VA 23294
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786188
- Sponsor's protocol ID
- N30-002
- Status last verified
- Oct 2015
- First submitted
- 4 Nov 2008
- Last updated
- 15 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 15292498Kritz-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.
PubMed 11025867Nelson 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.
PubMed 16670414Greene 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.
PubMed 1003364
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00786188
- Acronym / sponsor ID
- N30-002
- Conditions
- Hot Flashes
- Keywords
- Menopause, Vasomotor Symptoms, Hot flash, Perimenopause, Nonhormonal therapies, Climacteric symptoms, Mesafem, Low-Dose Mesylate salt of Paroxetine (LDMP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Noven TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Posted 12 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brisdelle (paroxetine mesylate) | Experimental | Drug: Brisdelle (paroxetine mesylate)Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. |
| Placebo - Sugar Pill | Placebo comparator | Drug: Sugar pillEligible subjects will be randomized to receive a sugar pill. |
Who may qualify
- Ages
- 41 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brisdelle (paroxetine mesylate)Also: Former Names: Mesafem capsules 7.5 mg or, LDMP (Low-Dose Mesylate salt of Paroxetine)Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg. | Drug | Brisdelle (paroxetine mesylate) |
| Sugar pillSubjects will receive a sugar pill. | Drug | Placebo - Sugar Pill |
Primary outcome
Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8
Time frame: 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
Time frame: 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.
9 secondary outcomes
Change From Baseline in Climacteric Symptoms at Week 8
Time frame: Week 8
Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8
Time frame: Week 4 and Week 8
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8
Time frame: Week 8
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4
Time frame: Week 4
Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4
Time frame: Week 4
Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8
Time frame: Week 4 and Week 8
Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8
Time frame: Week 8
Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8
Time frame: Week 4 and Week 8
Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8
Time frame: Week 4 and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15292498Fugate 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.
- Background: PubMed 11025867Kritz-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.
- Background: PubMed 16670414Nelson 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.
- Background: PubMed 1003364Greene 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick F. Freuen, MD principal investigator
North Spokane Women's Clinic, Spokane, WA 99207
Richard E. Hedrick, MD principal investigator
Hawthorne Medical Research, Inc., Winston-Salem, NC 27103
Samuel N. Lederman, MD principal investigator
Altus Research, Lake Worth, FL 33461
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brisdelle (paroxetine mesylate) and Sugar pill in people with Hot Flashes, run by Noven Therapeutics at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8 (time frame: Week 4 and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786188, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.