Phase 3
N=570
24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT01101841 ↗Enrolled (actual)
570
Serious AEs
3.5%
Results posted
Apr 2014
Primary outcome: Primary: Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12. — 10.83; 10.90; -4.13; -2.71 Hot flashes per day — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brisdelle (paroxetine mesylate) (Drug); Placebo capsules (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Noven Therapeutics
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12. |
10.83; 10.90; -4.13; -2.71; -5.31; -3.94 | <0.0001 sig |
| PRIMARY Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12. |
2.525; 2.532; -0.092; -0.059; -0.0126; -0.066 | 0.0368 sig |
| SECONDARY Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24. |
47.54; 36.27 | 0.0066 sig |
| SECONDARY Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median |
-28.50; -18.0; -41.00; -27.00 | — |
| SECONDARY Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median |
-8.50; -6.62; -13.15; -8.67 | — |
| SECONDARY Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median |
-22.0; -17.0; -31.50; -23.00 | — |
| SECONDARY Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median |
-0.033; -0.004; -0.045; -0.00 | — |
| SECONDARY Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median |
-0.039; -0.036; -0.052; -0.051 | — |
| SECONDARY Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median |
-3.00; -3.00; -4.00; -3.00 | — |
| SECONDARY Percentage of Responders |
35.56; 25.35; 49.30; 33.80 | — |
| SECONDARY Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS) |
35.48; 25.27; 46.62; 37.72 | — |
| SECONDARY Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY 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) |
26.03; 30.51; 15.89; 21.32 | — |
| SECONDARY Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale. |
67.88; 53.58; 69.88; 59.74 | — |
| SECONDARY Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression |
5.65; 2.44; 4.13; 5.24 | — |
| SECONDARY Assessment of Mood |
37.40; 42.39; 37.16; 44.23 | — |
| SECONDARY BMI Change From Baseline (kg/m2), Median |
0.00; 0.08; 0.15; 0.11 | — |
Summary
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
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
Data sourced from ClinicalTrials.gov (NCT01101841). 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.