Phase 3
N=614
Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
Postmenopausal Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT01361308 ↗Enrolled (actual)
614
Serious AEs
0.5%
Results posted
May 2014
Primary outcome: Primary: Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12. — 11.79; 11.65; -4.71; -3.36 Hot flash 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
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12. |
11.79; 11.65; -4.71; -3.36; -6.22; -5.33 | <0.0001 sig |
| PRIMARY Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12 |
2.528; 2.526; -0.091; -0.046; -0.104; -0.084 | 0.0017 sig |
| SECONDARY Clinical Meaningfulness Anchored to Patient Global Improvement (PGI-I) (%) |
50; 37; 51; 43 | 0.001 sig |
| SECONDARY Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median |
-8.33; -7.12; -12.00; -11.05 | — |
| SECONDARY Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median |
-31.00; -23.50; -46.00; -35.00 | — |
| SECONDARY Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median |
-28.00; -19.00; -35.00; -37.50 | — |
| SECONDARY Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median |
-0.055; 0.00; -0.043; -0.010 | — |
| SECONDARY Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median |
-0.023; -0.014; -0.079; -0.030 | — |
| SECONDARY Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median |
-3.00; -2.00; -4.00; -3.00 | — |
| SECONDARY Percentage of Responders |
40.20; 29.18; 49.83; 44.92 | — |
| SECONDARY Percentage of Patient Global Improvement (PGI) Scale Responders (%) |
68.21; 61.75; 72.82; 64.60 | — |
| SECONDARY Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS) |
39.00; 30.46; 46.51; 45.72 | — |
| SECONDARY Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score |
-0.34; -0.43; -0.36; -0.61 | — |
| 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) |
26.98; 32.00; 19.67; 21.95 | — |
| SECONDARY Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale. |
68.93; 57.89; 71.88; 63.92 | — |
| SECONDARY Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression |
3.56; 3.56; 2.02; 2.75 | — |
| SECONDARY Assessment of Mood |
39.29; 35.36; 43.90; 34.25 | — |
| SECONDARY BMI Change From Baseline (kg/m2), Median |
0.00; 0.04; 0.00; 0.17 | — |
Summary
The purpose of this study is to assess the safety & 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 at screening (inclusive)
- 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 to the screening visit
- Spontaneous amenorrhea for at least 12 consecutive months or
- Amenorrhea for at least 6 months and meet the biochemical criteria for menopause or
- Bilateral salpingo-oophorectomy ≥ 6 weeks with or without hysterectomy
Exclusion Criteria
- 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 (NCT01361308). 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.