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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• 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. History of hypersensitivity or adverse reaction to paroxetine mesylate

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

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

4. Family of investigational-site staff