24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noven Therapeutics
• Treatments: Paroxetine

Criteria

Inclusion Criteria:

1. Female, >40 years of age

2. 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

3. Spontaneous amenorrhea for at least 12 consecutive months

4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause

5. Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy

Exclusion Criteria:

1. BMI ≥ 40 kg/m²

2. Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS

3. History of self-injurious behavior

4. History of clinical diagnosis of depression; or treatment for depression

5. History of clinical diagnosis of borderline personality disorder

6. Use of an investigational study medication within 30 days prior to screening or during the study

7. Concurrent participation in another clinical trial or previous participation in this trial

8. Family of investigational-site staff