Phase 2
N=102
Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT00786188 ↗Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Mar 2014
Primary outcome: Primary: Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8 — 82.44; 83.18; 37.3; 28.5 Hot flashes — p=0.0177
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Brisdelle (paroxetine mesylate) (Drug); Sugar pill (Drug)
- Age
- Adult, Older Adult · 41+ yrs
- Sex
- Female
- Sponsor
- Noven Therapeutics
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8 |
82.44; 83.18; 37.3; 28.5; 42.2; 35.5 | 0.0177 sig |
| PRIMARY Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8 |
2.570; 2.539; 0.128; 0.072; 0.133; 0.066 | 0.0644 |
| SECONDARY Change From Baseline in Climacteric Symptoms at Week 8 |
16.63; 17.33; 12.31; 12.67 | — |
| SECONDARY Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8 |
211.9; 213.0; 114.7; 136.4; 102.6; 119.2 | — |
| SECONDARY Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8 |
2; 1; 0; 1; 0; 1 | — |
| SECONDARY Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4 |
21; 18 | — |
| SECONDARY Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4 |
12; 11 | — |
| SECONDARY Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8 |
73.91; 60.00; 64.58; 54.90 | — |
| SECONDARY Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8 |
17.98; 17.33; 18.00; 18.15 | — |
| SECONDARY Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8 |
33.33; 16.67; 37.14; 21.95 | — |
| SECONDARY Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8 |
27.85; 27.69; 28.14; 27.91; 27.73; 28.04 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT00786188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.